Trial Outcomes & Findings for Multi-site Anesthesia Randomized Controlled STudy of End Tidal Control Compared to Conventional Anesthesia Results (NCT NCT02972892)

NCT ID: NCT02972892

Last Updated: 2022-11-02

Results Overview

Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Steady state concentration is based on an extraction algorithm described in Appendix 2 of the protocol.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 248 participants
• Primary outcome timeframe: Duration of each steady state, an average of approximately 60 minutes
• Results posted on: 2022-11-02

Participant Flow

Enrollment began in June 2017 and was completed in July 2018. 248 subjects were enrolled at 4 sites. Males and females,18 years or older and scheduled to undergo general inhaled anesthesia during surgery, were screened for enrollment into this study. Subjects enrolled were randomized at a 1:1 ratio to either the Et Control Arm or the Control Arm. Randomization was stratified based on the Investigator, subject's pre-existing hypertension status, and subject's ASA status classification.

Subjects are considered enrolled at the time of informed consent. After consent, subjects were screened against the inclusion/exclusion criteria according to standard procedures of the investigational site.

Participant milestones

Measure	Et Control Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.	Control Arm Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an "end case" is confirmed on the Aisys CS2 at the end of the anesthesia case.
Overall Study STARTED	110	118
Overall Study COMPLETED	101	116
Overall Study NOT COMPLETED	9	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Multi-site Anesthesia Randomized Controlled STudy of End Tidal Control Compared to Conventional Anesthesia Results

Baseline characteristics by cohort

Measure	Et Control n=110 Participants Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.	Control Arm n=118 Participants Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an "end case" is confirmed on the Aisys CS2 at the end of the anesthesia case.	Total n=228 Participants Total of all reporting groups
Sex: Female, Male Female	51 Participants n=5 Participants	63 Participants n=7 Participants	114 Participants n=5 Participants
Sex: Female, Male Male	59 Participants n=5 Participants	55 Participants n=7 Participants	114 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	98 Participants n=5 Participants	105 Participants n=7 Participants	203 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) White	77 Participants n=5 Participants	81 Participants n=7 Participants	158 Participants n=5 Participants
Race (NIH/OMB) More than one race	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment United States	110 participants n=5 Participants	118 participants n=7 Participants	228 participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	90 Participants n=5 Participants	91 Participants n=7 Participants	181 Participants n=5 Participants
Age, Categorical >=65 years	20 Participants n=5 Participants	27 Participants n=7 Participants	47 Participants n=5 Participants

PRIMARY outcome

Timeframe: Duration of each steady state, an average of approximately 60 minutes

Population: Intent-to-treat population includes all randomized subjects

Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Steady state concentration is based on an extraction algorithm described in Appendix 2 of the protocol.

Outcome measures

Measure	Et Control n=110 Participants Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.	Control Arm n=118 Participants Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an "end case" is confirmed on the Aisys CS2 at the end of the anesthesia case.	ET Control - Sevoflurane Subjects randomized to the ET Control arm of the trial who received Sevoflurane as their inhaled anesthetic agent.	ET Control - All Summary of all Subjects randomized to the ET Control arm of the trial combining all anesthetic agents.
Percent Duration Without Large Deviation of End-Tidal Anesthetic Agent (EtAA) Based on Extraction Algorithm (ALG)	91.7 percent duration Standard Deviation 10.82	80.8 percent duration Standard Deviation 17.93	—	—

PRIMARY outcome

Timeframe: Duration of each steady state, an average of approximately 60 minutes

Population: Intent-to-treat population includes all randomized subjects

Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Data obtained using the clinicians' or Investigators' recorded target (TGT) values of anesthetic agent and oxygen for the Control Arm and using the set target values for the Et Control Arm.

Outcome measures

Measure	Et Control n=110 Participants Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.	Control Arm n=118 Participants Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an "end case" is confirmed on the Aisys CS2 at the end of the anesthesia case.	ET Control - Sevoflurane Subjects randomized to the ET Control arm of the trial who received Sevoflurane as their inhaled anesthetic agent.	ET Control - All Summary of all Subjects randomized to the ET Control arm of the trial combining all anesthetic agents.
Percent Duration Without Large Deviation of EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)	98.0 percent duration Standard Deviation 2.05	45.9 percent duration Standard Deviation 31.45	—	—

PRIMARY outcome

Timeframe: Duration of each steady state, an average of approximately 60 minutes

Population: Intent-to-treat population includes all randomized subjects

Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).

Outcome measures

Measure	Et Control n=110 Participants Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.	Control Arm n=118 Participants Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an "end case" is confirmed on the Aisys CS2 at the end of the anesthesia case.	ET Control - Sevoflurane Subjects randomized to the ET Control arm of the trial who received Sevoflurane as their inhaled anesthetic agent.	ET Control - All Summary of all Subjects randomized to the ET Control arm of the trial combining all anesthetic agents.
Percent Duration Without Large Deviation of End-Tidal Oxygen (EtO2) Based on Extraction Algorithm (ALG)	98.1 percent duration Standard Deviation 2.76	92.8 percent duration Standard Deviation 14.38	—	—

PRIMARY outcome

Timeframe: Duration of each steady state, an average of approximately 60 minutes

Population: Intent-to-treat population includes all randomized subjects

Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Values based on clinicians' or Investigators' recorded target values (TGT)

Outcome measures

Measure	Et Control n=110 Participants Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.	Control Arm n=118 Participants Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an "end case" is confirmed on the Aisys CS2 at the end of the anesthesia case.	ET Control - Sevoflurane Subjects randomized to the ET Control arm of the trial who received Sevoflurane as their inhaled anesthetic agent.	ET Control - All Summary of all Subjects randomized to the ET Control arm of the trial combining all anesthetic agents.
Percent Duration Without Large Deviation of EtO2 Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)	98.8 percent duration Standard Deviation 1.49	41.0 percent duration Standard Deviation 40.65	—	—

SECONDARY outcome

Timeframe: Duration of each steady state, an average of approximately 60 minutes

Population: Intent-to-treat population includes all randomized subjects

Response time: time to reach 90% of the desired change in EtAA steady state mean concentration. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).

Outcome measures

Measure	Et Control n=283 steady states Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.	Control Arm n=184 steady states Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an "end case" is confirmed on the Aisys CS2 at the end of the anesthesia case.	ET Control - Sevoflurane Subjects randomized to the ET Control arm of the trial who received Sevoflurane as their inhaled anesthetic agent.	ET Control - All Summary of all Subjects randomized to the ET Control arm of the trial combining all anesthetic agents.
Efficacy Response Time EtAA Based on Extraction Algorithm (ALG)	73 Seconds Standard Deviation 174.1	196 Seconds Standard Deviation 378.3	—	—

SECONDARY outcome

Timeframe: Duration of each steady state, an average of approximately 60 minutes

Population: Intent-to-treat population includes all randomized subjects

time to reach 90% of the desired change in EtAA and EtO2 steady state mean concentration. Values based on clinicians' or Investigators' recorded values (TGT).

Outcome measures

Measure	Et Control n=520 steady states Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.	Control Arm n=281 steady states Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an "end case" is confirmed on the Aisys CS2 at the end of the anesthesia case.	ET Control - Sevoflurane Subjects randomized to the ET Control arm of the trial who received Sevoflurane as their inhaled anesthetic agent.	ET Control - All Summary of all Subjects randomized to the ET Control arm of the trial combining all anesthetic agents.
Efficacy: Response Time for EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)	23 Seconds Standard Deviation 40.9	196 Seconds Standard Deviation 455.0	—	—

SECONDARY outcome

Timeframe: Duration of each steady state, an average of approximately 60 minutes.

Population: Intent-to-treat population includes all randomized subjects

Response time: time to reach 90% of the desired change in EtO2 steady state mean concentration. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).

Outcome measures

Measure	Et Control n=238 steady states Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.	Control Arm n=318 steady states Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an "end case" is confirmed on the Aisys CS2 at the end of the anesthesia case.	ET Control - Sevoflurane Subjects randomized to the ET Control arm of the trial who received Sevoflurane as their inhaled anesthetic agent.	ET Control - All Summary of all Subjects randomized to the ET Control arm of the trial combining all anesthetic agents.
Efficacy Response Time for EtO2 Based on Extraction Algorithm (ALG)	93 Seconds Standard Deviation 77.3	246 Seconds Standard Deviation 346.8	—	—

SECONDARY outcome

Timeframe: Duration of each steady state, an average of approximately 60 minutes

Population: Intent-to-treat population includes all randomized subjects

Response time: time to reach 90% of the desired change in EtAA and EtO2 steady state mean concentration. Values based on clinicians' or Investigators' recorded values (TGT).

Outcome measures

Measure	Et Control n=240 steady states Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.	Control Arm n=209 steady states Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an "end case" is confirmed on the Aisys CS2 at the end of the anesthesia case.	ET Control - Sevoflurane Subjects randomized to the ET Control arm of the trial who received Sevoflurane as their inhaled anesthetic agent.	ET Control - All Summary of all Subjects randomized to the ET Control arm of the trial combining all anesthetic agents.
Efficacy: Response Time for EtO2 Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)	129 Seconds Standard Deviation 451.7	406 Seconds Standard Deviation 727.8	—	—

SECONDARY outcome

Timeframe: Duration of each steady state, an average of approximately 60 minutes

Population: Intent-to-treat population includes all randomized subjects

Settling time: time to achieve the desired EtAA steady state mean concentration. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).

Outcome measures

Measure	Et Control n=283 steady states Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.	Control Arm n=184 steady states Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an "end case" is confirmed on the Aisys CS2 at the end of the anesthesia case.	ET Control - Sevoflurane Subjects randomized to the ET Control arm of the trial who received Sevoflurane as their inhaled anesthetic agent.	ET Control - All Summary of all Subjects randomized to the ET Control arm of the trial combining all anesthetic agents.
Efficacy: Settling Time for EtAA Based on the Extraction Algorithm (ALG)	105 Seconds Standard Deviation 181.9	165 Seconds Standard Deviation 186.4	—	—

SECONDARY outcome

Timeframe: Duration of each steady state, an average of approximately 60 minutes

Population: Intent-to-treat population includes all randomized subjects

Settling time: time to achieve the desired EtAA steady state mean concentration. Values based on clinicians' or Investigators' recorded values (TGT).

Outcome measures

Measure	Et Control n=520 steady states Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.	Control Arm n=281 steady states Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an "end case" is confirmed on the Aisys CS2 at the end of the anesthesia case.	ET Control - Sevoflurane Subjects randomized to the ET Control arm of the trial who received Sevoflurane as their inhaled anesthetic agent.	ET Control - All Summary of all Subjects randomized to the ET Control arm of the trial combining all anesthetic agents.
Efficacy: Settling Time for EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)	23 Seconds Standard Deviation 40.9	196 Seconds Standard Deviation 455.0	—	—

SECONDARY outcome

Timeframe: Duration of each steady state, an average of approximately 60 minutes

Population: Intent-to-treat population includes all randomized subjects

Settling time: time to achieve the desired EtO2 steady state mean concentration. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).

Outcome measures

Measure	Et Control n=238 steady states Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.	Control Arm n=318 steady states Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an "end case" is confirmed on the Aisys CS2 at the end of the anesthesia case.	ET Control - Sevoflurane Subjects randomized to the ET Control arm of the trial who received Sevoflurane as their inhaled anesthetic agent.	ET Control - All Summary of all Subjects randomized to the ET Control arm of the trial combining all anesthetic agents.
Efficacy: Settling Time for EtO2 Based on the Extraction Algorithm (ALG)	123 Seconds Standard Deviation 117.5	235 Seconds Standard Deviation 213.2	—	—

SECONDARY outcome

Timeframe: Duration of each steady state, an average of approximately 60 minutes

Population: Intent-to-treat population includes all randomized subjects

time to achieve the desired EtO2 steady state mean concentration. Values based on clinicians' or Investigators' recorded values (TGT).

Outcome measures

Measure	Et Control n=240 steady states Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.	Control Arm n=209 steady states Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an "end case" is confirmed on the Aisys CS2 at the end of the anesthesia case.	ET Control - Sevoflurane Subjects randomized to the ET Control arm of the trial who received Sevoflurane as their inhaled anesthetic agent.	ET Control - All Summary of all Subjects randomized to the ET Control arm of the trial combining all anesthetic agents.
Efficacy: Settling Time for EtO2 Based on Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)	167 Seconds Standard Deviation 121.1	815 Seconds Standard Deviation 1327.2	—	—

SECONDARY outcome

Timeframe: Duration of each steady state, an average of approximately 60 minutes

Population: Intent-to-treat population includes all randomized subjects

Overshoot amount of the desired EtAA from steady state mean concentration. Command Overshoot is defined as the maximum value beyond the desired end tidal concentration from the start of the step change until the Settling Time. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).

Outcome measures

Measure	Et Control n=283 steady states Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.	Control Arm n=184 steady states Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an "end case" is confirmed on the Aisys CS2 at the end of the anesthesia case.	ET Control - Sevoflurane Subjects randomized to the ET Control arm of the trial who received Sevoflurane as their inhaled anesthetic agent.	ET Control - All Summary of all Subjects randomized to the ET Control arm of the trial combining all anesthetic agents.
Efficacy: Overshoot Amount of the Desired EtAA Based on Extraction Algorithm (ALG)	8.85 percent to mean Standard Deviation 12.026	6.54 percent to mean Standard Deviation 13.576	—	—

SECONDARY outcome

Timeframe: Duration of each steady state, an average of approximately 60 minutes

Population: Intent-to-treat population includes all randomized subjects

Overshoot amount of the desired EtAA from steady state mean concentration. Command Overshoot is defined as the maximum value beyond the desired end tidal concentration from the start of the step change until the Settling Time. Values based on clinicians' or Investigators' recorded values (TGT).

Outcome measures

Measure	Et Control n=519 steady states Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.	Control Arm n=278 steady states Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an "end case" is confirmed on the Aisys CS2 at the end of the anesthesia case.	ET Control - Sevoflurane Subjects randomized to the ET Control arm of the trial who received Sevoflurane as their inhaled anesthetic agent.	ET Control - All Summary of all Subjects randomized to the ET Control arm of the trial combining all anesthetic agents.
Efficacy: Overshoot Amount of the Desired EtAA Amount Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)	5.28 percent to mean Standard Deviation 6.953	12.09 percent to mean Standard Deviation 27.085	—	—

SECONDARY outcome

Timeframe: Duration of each steady state, an average of approximately 60 minutes

Population: Intent-to-treat population includes all randomized subjects

Overshoot amount of the desired EtO2 from steady state mean concentration. Command Overshoot is defined as the maximum value beyond the desired end tidal concentration from the start of the step change until the Settling Time. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).

Outcome measures

Measure	Et Control n=238 steady states Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.	Control Arm n=318 steady states Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an "end case" is confirmed on the Aisys CS2 at the end of the anesthesia case.	ET Control - Sevoflurane Subjects randomized to the ET Control arm of the trial who received Sevoflurane as their inhaled anesthetic agent.	ET Control - All Summary of all Subjects randomized to the ET Control arm of the trial combining all anesthetic agents.
Efficacy: Overshoot Amount of Desired EtO2 Amount Based on the Extraction Algorithm (ALG)	3.47 percent to mean Standard Deviation 8.238	2.80 percent to mean Standard Deviation 11.373	—	—

SECONDARY outcome

Timeframe: Duration of each steady state, an average of approximately 60 minutes

Population: Intent-to-treat population includes all randomized subjects

Overshoot amount of the desired EtO2 from steady state mean concentration. Command Overshoot is defined as the maximum value beyond the desired end tidal concentration from the start of the step change until the Settling Time. Values based on clinicians' or Investigators' recorded values (TGT).

Outcome measures

Measure	Et Control n=240 steady states Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.	Control Arm n=209 steady states Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an "end case" is confirmed on the Aisys CS2 at the end of the anesthesia case.	ET Control - Sevoflurane Subjects randomized to the ET Control arm of the trial who received Sevoflurane as their inhaled anesthetic agent.	ET Control - All Summary of all Subjects randomized to the ET Control arm of the trial combining all anesthetic agents.
Efficacy: Overshoot Amount of Desired EtO2 Amount Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)	2.14 percent to mean Standard Deviation 6.277	11.13 percent to mean Standard Deviation 20.662	—	—

SECONDARY outcome

Timeframe: Duration of surgery, average of 112.1 minutes (+/- 78.7 minutes)

Population: Subjects randomized to the ET control arm of the study who underwent surgery

Accuracy of Et Control in maintaining EtAA control between user set target and settling end tidal concentrations. Calculated for Et Control arm only. The accuracy measures include absolute difference between steady state and set EtAA concentrations. The acceptable limits defined by the primary endpoint were: 0.1% of Isoflurane, 0.2% for Sevoflurane, 0.6% for Desflurane. As a measure of Absolute Difference between Steady State and Set EtAA Concentration (%). Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).

Outcome measures

Measure	Et Control n=50 steady states Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.	Control Arm n=54 steady states Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an "end case" is confirmed on the Aisys CS2 at the end of the anesthesia case.	ET Control - Sevoflurane n=178 steady states Subjects randomized to the ET Control arm of the trial who received Sevoflurane as their inhaled anesthetic agent.	ET Control - All n=282 steady states Summary of all Subjects randomized to the ET Control arm of the trial combining all anesthetic agents.
Accuracy of Et Control in Maintaining EtAA Control Between User Set Target and Settling End Tidal Concentrations Based on the Extraction Algorithm (ALG)	0.11 Absolute Difference (%) Standard Deviation 0.056	0.04 Absolute Difference (%) Standard Deviation 0.031	0.04 Absolute Difference (%) Standard Deviation 0.026	0.05 Absolute Difference (%) Standard Deviation 0.043

SECONDARY outcome

Timeframe: Duration of Surgery

Population: Subjects Randomized to the ET control arm of the study who underwent surgery

Accuracy of ET Control in maintatining EtAA between user set target and settling end tidal concentrations. Calculated for ET Control arm only. The accuracy measures include absolute difference between steady state and set EtAA concentrations. The acceptable limits defined by the primary endpoint were: 0.1% of Isoflurane, 0.2% for Sevoflurane, 0.6% for Desflurane. Values based on clinicians' or Investigators' recorded values (TGT).

Outcome measures

Measure	Et Control n=85 steady states Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.	Control Arm n=72 steady states Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an "end case" is confirmed on the Aisys CS2 at the end of the anesthesia case.	ET Control - Sevoflurane n=362 steady states Subjects randomized to the ET Control arm of the trial who received Sevoflurane as their inhaled anesthetic agent.	ET Control - All n=519 steady states Summary of all Subjects randomized to the ET Control arm of the trial combining all anesthetic agents.
Accuracy of ET Control in Maintaining EtAA Control Between User Set Target and Settling End Tidal Concentrations Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)	0.10 Absolute Difference (%) Standard Deviation 0.054	0.03 Absolute Difference (%) Standard Deviation 0.031	0.04 Absolute Difference (%) Standard Deviation 0.027	0.05 Absolute Difference (%) Standard Deviation 0.04

SECONDARY outcome

Timeframe: Duration of surgery, average of 112.1 minutes (+/- 78.7 minutes)

Population: Subjects randomized to the ET control arm of the study who underwent surgery.

Accuracy of Et Control in maintaining EtO2 control between user set target and settling end tidal concentrations. Calculated for Et Control arm only. outcome measures the absolute difference between Steady State and Set EtO2 Concentrations. The acceptable limit defined by the primary endpoint was < 5% v/v. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).

Outcome measures

Measure	Et Control n=58 steady states Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.	Control Arm n=34 steady states Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an "end case" is confirmed on the Aisys CS2 at the end of the anesthesia case.	ET Control - Sevoflurane n=146 steady states Subjects randomized to the ET Control arm of the trial who received Sevoflurane as their inhaled anesthetic agent.	ET Control - All n=238 steady states Summary of all Subjects randomized to the ET Control arm of the trial combining all anesthetic agents.
Accuracy of Et Control in Maintaining EtO2 Between User Set Target and Settling End Tidal Concentrations Based on the Extraction Algorithm (ALG)	0.57 Absolute Difference (%) Standard Deviation 0.594	0.62 Absolute Difference (%) Standard Deviation 0.613	0.64 Absolute Difference (%) Standard Deviation 0.932	0.62 Absolute Difference (%) Standard Deviation 0.818

SECONDARY outcome

Timeframe: Duration of surgery, average of 112.1 minutes (+/- 78.7 minutes)

Population: Subjects randomized to the ET control arm of the study who underwent surgery

Accuracy of Et Control in maintaining EtO2 control between user set target and settling end tidal concentrations. Calculated for Et Control arm only. outcome measures the absolute difference between Steady State and Set EtO2 Concentrations. The acceptable limit defined by the primary endpoint was < 5% v/v. Values based on clinicians' or Investigators' recorded values (TGT).

Outcome measures

Measure	Et Control n=60 steady states Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.	Control Arm n=33 steady states Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an "end case" is confirmed on the Aisys CS2 at the end of the anesthesia case.	ET Control - Sevoflurane n=147 steady states Subjects randomized to the ET Control arm of the trial who received Sevoflurane as their inhaled anesthetic agent.	ET Control - All n=240 steady states Summary of all Subjects randomized to the ET Control arm of the trial combining all anesthetic agents.
Accuracy of Et Control in Maintaining EtO2 Between User Set Target and Settling End Tidal Concentrations Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)	0.62 Absolute Difference (%) Standard Deviation 0.632	0.61 Absolute Difference (%) Standard Deviation 0.585	0.64 Absolute Difference (%) Standard Deviation 0.863	0.63 Absolute Difference (%) Standard Deviation 0.774

OTHER_PRE_SPECIFIED outcome

Timeframe: Duration of Procedure

Usage of inhaled anesthetic agent

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Duration of Procedure

Number of user interactions

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: End of surgery to time of last breath

Time to discharge from the operating room

Outcome measures

Outcome data not reported

Adverse Events

Et Control

Serious events: 1 serious events

Other events: 36 other events

Deaths: 0 deaths

Control Arm

Serious events: 1 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Measure	Et Control n=104 participants at risk Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.	Control Arm n=116 participants at risk Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an "end case" is confirmed on the Aisys CS2 at the end of the anesthesia case.
Hepatobiliary disorders Bile Leak	0.00% 0/104 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	0.86% 1/116 • Number of events 1 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Eye disorders Vision Loss	0.96% 1/104 • Number of events 1 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	0.00% 0/116 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.

Other adverse events

Measure	Et Control n=104 participants at risk Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.	Control Arm n=116 participants at risk Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an "end case" is confirmed on the Aisys CS2 at the end of the anesthesia case.
Gastrointestinal disorders Nausea	2.9% 3/104 • Number of events 3 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	3.4% 4/116 • Number of events 4 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Nervous system disorders Confusion	0.96% 1/104 • Number of events 1 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	0.00% 0/116 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Gastrointestinal disorders Abdominal Cramps	0.96% 1/104 • Number of events 1 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	0.00% 0/116 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Renal and urinary disorders Bladder Spasms	0.96% 1/104 • Number of events 1 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	0.00% 0/116 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Surgical and medical procedures Post-Operative Pain	0.96% 1/104 • Number of events 1 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	0.86% 1/116 • Number of events 1 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Surgical and medical procedures Inadvertent Cystotomy and Repair	0.00% 0/104 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	0.86% 1/116 • Number of events 1 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Surgical and medical procedures Post Operative Pain of 10	0.00% 0/104 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	0.86% 1/116 • Number of events 1 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Surgical and medical procedures Intraoperative Bleeding	0.96% 1/104 • Number of events 1 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	0.00% 0/116 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Surgical and medical procedures Intractable Pain	0.96% 1/104 • Number of events 1 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	0.00% 0/116 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Surgical and medical procedures Pain 7 out of 10	1.9% 2/104 • Number of events 2 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	1.7% 2/116 • Number of events 2 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Surgical and medical procedures Elevated Heart Rate and Breathing	0.00% 0/104 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	0.86% 1/116 • Number of events 1 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Renal and urinary disorders Bladder Wall Damage	0.96% 1/104 • Number of events 1 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	0.00% 0/116 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Musculoskeletal and connective tissue disorders Left Thigh Weakness	0.96% 1/104 • Number of events 1 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	0.00% 0/116 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Surgical and medical procedures Pain 8 of 10	1.9% 2/104 • Number of events 2 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	2.6% 3/116 • Number of events 3 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Vascular disorders Hypotension (general)	2.9% 3/104 • Number of events 3 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	2.6% 3/116 • Number of events 3 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Psychiatric disorders Agitation	0.96% 1/104 • Number of events 1 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	0.00% 0/116 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Vascular disorders NIBP SBP>160 mmHg for >5 min	14.4% 15/104 • Number of events 15 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	20.7% 24/116 • Number of events 24 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Vascular disorders NIBP MAP >120 mmHg for > 5 min	4.8% 5/104 • Number of events 5 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	4.3% 5/116 • Number of events 5 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Cardiac disorders HR <45bpm more than 5 min	1.9% 2/104 • Number of events 2 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	0.00% 0/116 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Surgical and medical procedures Emergence Delay	0.96% 1/104 • Number of events 1 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	0.00% 0/116 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
General disorders Throat Pain	0.00% 0/104 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	0.86% 1/116 • Number of events 1 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Surgical and medical procedures Oral Pain	0.00% 0/104 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	0.86% 1/116 • Number of events 1 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Surgical and medical procedures Pain 9 of 10	0.96% 1/104 • Number of events 1 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	0.86% 1/116 • Number of events 1 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Surgical and medical procedures Intermittent Pain	0.00% 0/104 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	0.86% 1/116 • Number of events 1 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Gastrointestinal disorders Vomiting	0.00% 0/104 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	0.86% 1/116 • Number of events 1 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
General disorders Dizziness	0.96% 1/104 • Number of events 1 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	0.00% 0/116 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Surgical and medical procedures Dizziness, photophobia, and delay in discharge from PACU	0.00% 0/104 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	0.86% 1/116 • Number of events 1 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Renal and urinary disorders Low Urine Output	0.96% 1/104 • Number of events 1 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	0.00% 0/116 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Blood and lymphatic system disorders Hematoma	0.00% 0/104 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	0.86% 1/116 • Number of events 1 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Respiratory, thoracic and mediastinal disorders Large Pneumothorax	0.96% 1/104 • Number of events 1 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	0.00% 0/116 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Respiratory, thoracic and mediastinal disorders SpO2 < 90% for more than 5 min	1.9% 2/104 • Number of events 2 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	0.00% 0/116 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/104 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	0.86% 1/116 • Number of events 1 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Surgical and medical procedures Severe Post Operative Pain	0.00% 0/104 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	0.86% 1/116 • Number of events 1 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Cardiac disorders HR >110bpm more than 5 min	6.7% 7/104 • Number of events 7 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	4.3% 5/116 • Number of events 5 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.00% 0/104 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	0.86% 1/116 • Number of events 1 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Vascular disorders NIPB MAP <55 mmHg for >5 min	2.9% 3/104 • Number of events 3 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	0.86% 1/116 • Number of events 1 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Vascular disorders NIBP SBP <70 mmHg for >5 min	1.9% 2/104 • Number of events 2 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	0.00% 0/116 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Renal and urinary disorders Urinary Tract Infection	0.00% 0/104 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	0.86% 1/116 • Number of events 1 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
General disorders Fever	0.00% 0/104 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	0.86% 1/116 • Number of events 1 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Eye disorders Corneal Abrasion	0.96% 1/104 • Number of events 1 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.	0.00% 0/116 • Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.

Additional Information

Research Program Integrator

GE Healthcare

Phone: 262-290-6037

Email: meghan.terry@ge.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60