Trial Outcomes & Findings for Estimate the Behavior of Chinese Anesthesiologists Practicing General Anesthesia With Sevoflurane (NCT NCT01199471)

NCT ID: NCT01199471

Last Updated: 2012-01-26

Results Overview

Anesthesiologist satisfaction with the anesthesia administered to each patient during surgery was recorded at the end of the operation using a Numeric Analog Scale (NAS) from 0 (not satisfied at all) to 10 (completely satisfied) are summarized.

• Recruitment status: COMPLETED
• Target enrollment: 4000 participants
• Primary outcome timeframe: Within 24 hours
• Results posted on: 2012-01-26

Participant Flow

Participant milestones

Measure	Chinese Patients Requiring Surgery With Anesthesia Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
Overall Study STARTED	4000
Overall Study COMPLETED	3994
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Chinese Patients Requiring Surgery With Anesthesia Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
Overall Study Protocol Violation	4
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	1

Baseline Characteristics

Estimate the Behavior of Chinese Anesthesiologists Practicing General Anesthesia With Sevoflurane

Baseline characteristics by cohort

Measure	Chinese Patients Requiring Surgery With Anesthesia n=3997 Participants Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
Age Continuous	45.26 years STANDARD_DEVIATION 13.52 • n=5 Participants
Sex: Female, Male Female	2344 Participants n=5 Participants
Sex: Female, Male Male	1653 Participants n=5 Participants
Region of Enrollment China	3997 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 24 hours

Population: 400 participating anesthesiologists evaluated their satisfaction with anesthesia (sevoflurane) administered to patients during surgery. All available data for 3,993 patients are included and summarized.

Anesthesiologist satisfaction with the anesthesia administered to each patient during surgery was recorded at the end of the operation using a Numeric Analog Scale (NAS) from 0 (not satisfied at all) to 10 (completely satisfied) are summarized.

Outcome measures

Measure	Chinese Patients Requiring Surgery With Anesthesia n=3993 Participants Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 through 3, who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA).
Anesthesiologist Satisfaction With the Anesthesia Recorded at the End of the Operation Using a Numeric Analog Scale (NAS)	8.85 units on a scale Standard Deviation 0.96

PRIMARY outcome

Timeframe: Within 24 hours

Population: All available data were included in the analysis.

Patient satisfaction with the anesthesia recorded at the end of the operation within 24 hours using a numeric analog scale (NAS) from 0 (not satisfied at all) to 10 (completely satisfied) are summarized.

Outcome measures

Measure	Chinese Patients Requiring Surgery With Anesthesia n=3972 Participants Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 through 3, who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA).
Patient Satisfaction With the Anesthesia Recorded at the End of the Operation Using a Numeric Analog Scale (NAS)	8.88 units on a scale Standard Deviation 0.93

SECONDARY outcome

Timeframe: Up to 10 minutes

Population: All available data were included in the analysis.

The time to loss of consciousness was measured from commencement of administration of anesthesia to the patient's loss of consciousness (no response to command).

Outcome measures

Measure	Chinese Patients Requiring Surgery With Anesthesia n=3921 Participants Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 through 3, who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA).
Time to Loss of Consciousness of Patients Administered Anesthesia	1.65 minutes Standard Deviation 0.92

SECONDARY outcome

Timeframe: Up to 10 minutes

Population: All available data were included in the analysis.

The time to intubation of the patients was measured from the commencement of administration of anesthesia to intubation of each patient.

Outcome measures

Measure	Chinese Patients Requiring Surgery With Anesthesia n=3944 Participants Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 through 3, who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA).
Time to Intubation of Patients	4.06 minutes Standard Deviation 1.74

SECONDARY outcome

Timeframe: Every minute after cessation of anesthesia until the patient opened his/her eyes

Population: All available data were included in the analysis.

Time to eye opening of patients was measured by the time from cessation of anesthesia administration to opening of the patients' eyes. After cessation of anesthesia, the investigators lightly tapped on the patients forehead or shoulder and asked the patients to open their eyes. This process was repeated about every minute until the patients opened their eyes.

Outcome measures

Measure	Chinese Patients Requiring Surgery With Anesthesia n=2605 Participants Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 through 3, who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA).
Time to Eye Opening of Patients	14.02 minutes Standard Deviation 8.35

SECONDARY outcome

Timeframe: Every minute after cessation of anesthesia until the patient was extubated

Population: All available data were included in the analysis.

The time to extubation of patients was measured from cessation of anesthesia administration to tracheal extubation of the patient.

Outcome measures

Measure	Chinese Patients Requiring Surgery With Anesthesia n=2617 Participants Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 through 3, who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA).
Time to Extubation of Patients	16.33 minutes Standard Deviation 9.59

Adverse Events

Chinese Patients Requiring Surgery With Anesthesia

Serious events: 0 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Chinese Patients Requiring Surgery With Anesthesia n=3997 participants at risk Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
Cardiac disorders Arrhythmia	0.03% 1/3997 • Number of events 1 • All adverse events experienced by patients that occurred during the course of the study were reported. Adverse events occurring during the study were reported up to 30 days after the last dose of study treatment.
Cardiac disorders Sinus bradycardia	0.10% 4/3997 • Number of events 4 • All adverse events experienced by patients that occurred during the course of the study were reported. Adverse events occurring during the study were reported up to 30 days after the last dose of study treatment.
Cardiac disorders Sinus tachycardia	0.05% 2/3997 • Number of events 2 • All adverse events experienced by patients that occurred during the course of the study were reported. Adverse events occurring during the study were reported up to 30 days after the last dose of study treatment.
Gastrointestinal disorders Postoperative nausea and vomiting	0.15% 6/3997 • Number of events 6 • All adverse events experienced by patients that occurred during the course of the study were reported. Adverse events occurring during the study were reported up to 30 days after the last dose of study treatment.
Immune system disorders Allergic reaction	0.03% 1/3997 • Number of events 1 • All adverse events experienced by patients that occurred during the course of the study were reported. Adverse events occurring during the study were reported up to 30 days after the last dose of study treatment.
Immune system disorders Asthma	0.03% 1/3997 • Number of events 1 • All adverse events experienced by patients that occurred during the course of the study were reported. Adverse events occurring during the study were reported up to 30 days after the last dose of study treatment.
Investigations Slow heart rhythm	0.05% 2/3997 • Number of events 2 • All adverse events experienced by patients that occurred during the course of the study were reported. Adverse events occurring during the study were reported up to 30 days after the last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	0.03% 1/3997 • Number of events 1 • All adverse events experienced by patients that occurred during the course of the study were reported. Adverse events occurring during the study were reported up to 30 days after the last dose of study treatment.
Vascular disorders Hypotension	0.35% 14/3997 • Number of events 14 • All adverse events experienced by patients that occurred during the course of the study were reported. Adverse events occurring during the study were reported up to 30 days after the last dose of study treatment.
Vascular disorders Hypertension	0.18% 7/3997 • Number of events 8 • All adverse events experienced by patients that occurred during the course of the study were reported. Adverse events occurring during the study were reported up to 30 days after the last dose of study treatment.
Nervous system disorders Agitation during the operation	0.05% 2/3997 • Number of events 2 • All adverse events experienced by patients that occurred during the course of the study were reported. Adverse events occurring during the study were reported up to 30 days after the last dose of study treatment.
Nervous system disorders Emergence agitation	0.05% 2/3997 • Number of events 2 • All adverse events experienced by patients that occurred during the course of the study were reported. Adverse events occurring during the study were reported up to 30 days after the last dose of study treatment.

Additional Information

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