Trial Outcomes & Findings for Compare Pharmaceutical Economics and Efficacy of Sevoflurane With Low Fresh Gas Flow Balanced Anesthesia, Propofol Target Controlled Infusion Anesthesia and Propofol Induction Sevoflurane Maintenance Anesthesia (NCT NCT01191476)

NCT ID: NCT01191476

Last Updated: 2012-07-03

Results Overview

\[Cost of VIMA = unit price of sevoflurane X used volume of sevoflurane\]; \[Cost of TIVA = unit price of propofol X total volume of propofol in the syringe\]; \[Cost of Propofol Induction and Sevoflurane Maintenance = unit price of propofol X total volume of propofol in the syringe + unit price of sevoflurane X volume of sevoflurane in the syringe\]. The total volume of propofol in the syringe was calculated, even if all the anesthetic was not used, because it could not be reused.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 336 participants
• Primary outcome timeframe: Anesthetic Duration between 1 to 3 Hours
• Results posted on: 2012-07-03

Participant Flow

Subjects between the ages of 18 and 65 were recruited from 4 hospitals in 4 cities in China. They were required to have elective laparoscopic, in-patient surgery with a predicted anesthetic duration between 1 to 3 hours. Subjects with ASA physical status I or II were enrolled and were to have had the ability to provide informed consent.

The study was a prospective, randomized (1:1:1), open-label, multi-center study comparing the cost of inhalational anesthesia with sevoflurane to intravenous (IV) anesthesia with propofol, or propofol for induction and sevoflurane for maintenance of anesthesia. The full analysis set was used for determination of all primary and secondary endpoints.

Participant milestones

Measure	Sevoflurane Inhalational induction and maintenance anesthesia with sevoflurane.	Propofol Target controlled infusion anesthesia with propofol for induction and maintenance.	Propofol Induction Sevoflurane Maintenance Propofol induction and sevoflurane maintenance anesthesia.
Overall Study STARTED	112	111	111
Overall Study COMPLETED	109	107	111
Overall Study NOT COMPLETED	3	4	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Compare Pharmaceutical Economics and Efficacy of Sevoflurane With Low Fresh Gas Flow Balanced Anesthesia, Propofol Target Controlled Infusion Anesthesia and Propofol Induction Sevoflurane Maintenance Anesthesia

Baseline characteristics by cohort

Measure	Sevoflurane n=112 Participants Inhalational induction and maintenance anesthesia with sevoflurane.	Propofol n=111 Participants Target controlled infusion anesthesia with propofol for induction and maintenance.	Propofol Induction Sevoflurane Maintenance n=111 Participants Propofol induction and sevoflurane maintenance anesthesia.	Total n=334 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	112 Participants n=5 Participants	111 Participants n=7 Participants	111 Participants n=5 Participants	334 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age Continuous	42.29 years STANDARD_DEVIATION 12.15 • n=5 Participants	43.26 years STANDARD_DEVIATION 12.05 • n=7 Participants	42.51 years STANDARD_DEVIATION 11.81 • n=5 Participants	42.71 years STANDARD_DEVIATION 11.96 • n=4 Participants
Sex: Female, Male Female	92 Participants n=5 Participants	92 Participants n=7 Participants	87 Participants n=5 Participants	271 Participants n=4 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	19 Participants n=7 Participants	24 Participants n=5 Participants	63 Participants n=4 Participants
Region of Enrollment China	112 participants n=5 Participants	111 participants n=7 Participants	111 participants n=5 Participants	334 participants n=4 Participants

PRIMARY outcome

Timeframe: Anesthetic Duration between 1 to 3 Hours

Population: The full analysis set was used for the determination of cost of anesthesia.

[Cost of VIMA = unit price of sevoflurane X used volume of sevoflurane];

[Cost of TIVA = unit price of propofol X total volume of propofol in the syringe];

[Cost of Propofol Induction and Sevoflurane Maintenance = unit price of propofol X total volume of propofol in the syringe + unit price of sevoflurane X volume of sevoflurane in the syringe].

The total volume of propofol in the syringe was calculated, even if all the anesthetic was not used, because it could not be reused.

Outcome measures

Measure	Sevoflurane n=112 Participants Inhalational sevoflurane for induction and maintenance of anesthesia	Propofol n=111 Participants IV Propofol for induction and maintenance of anesthesia	Propofol Induction Sevoflurane Maintenance n=111 Participants Propofol bolus for IV induction and sevoflurane for maintenance of anesthesia
Cost of Volatile Induction and Maintenance Anesthesia (VIMA) With Sevoflurane, Total Intravenous Anesthesia (TIVA) With Propofol, or Intravenous Induction With Propofol and Inhalational Maintenance With Sevoflurane	380.78 Yuan Standard Deviation 108.53	548.52 Yuan Standard Deviation 195.14	269.40 Yuan Standard Deviation 74.04

SECONDARY outcome

Timeframe: Up to 10 minutes

Loss of consciousness was measured from the time the anesthetic was administered until loss of consciousness (no response to command) occurred. Inhalational induction was induced with sevoflurane via vital capacity induction at 8%. Intravenous induction was induced with propofol at 4 µg/mL via target controlled infusion (TCI). In subjects who received both anesthetic agents, a bolus dose of propofol 1.5 mg/kg was used for induction.

Outcome measures

Measure	Sevoflurane n=112 Participants Inhalational sevoflurane for induction and maintenance of anesthesia	Propofol n=111 Participants IV Propofol for induction and maintenance of anesthesia	Propofol Induction Sevoflurane Maintenance n=111 Participants Propofol bolus for IV induction and sevoflurane for maintenance of anesthesia
Time to Loss of Consciousness	48.54 seconds Standard Deviation 22.77	100.32 seconds Standard Deviation 55.15	68.76 seconds Standard Deviation 34.96

SECONDARY outcome

Timeframe: Every minute after anesthesia was stopped until the subjects' eyes opened

Measured from the time sevoflurane or propofol administration was stopped until the subject's eyes were opened. The investigator tapped the subject on the forehead or shoulder after anesthesia was stopped and asked them to open their eyes. This process was repeated approximately every minute until eye opening occurred.

Outcome measures

Measure	Sevoflurane n=112 Participants Inhalational sevoflurane for induction and maintenance of anesthesia	Propofol n=111 Participants IV Propofol for induction and maintenance of anesthesia	Propofol Induction Sevoflurane Maintenance n=111 Participants Propofol bolus for IV induction and sevoflurane for maintenance of anesthesia
Time to Eye Opening	8.38 Minutes Standard Deviation 3.66	9.79 Minutes Standard Deviation 6.92	8.69 Minutes Standard Deviation 3.50

SECONDARY outcome

Timeframe: Every minute after anesthesia was stopped until extubation occurred

Population: Measurement

Time to extubation was measured from the time sevoflurane or propofol administration was stopped until tracheal extubation occurred. Criteria to determine extubation included a train of four stimulus > 0.9 (a method to measure the magnitude and type of neuromuscular block, a ratio of the fourth response to the first one), a tidal volume > 5 mL/kg, minute ventilation > 3 L, a respiratory rate of > 10 breaths/minute, an end tidal carbon dioxide < 45 mmHg, and eye opening has occurred.

Outcome measures

Measure	Sevoflurane n=112 Participants Inhalational sevoflurane for induction and maintenance of anesthesia	Propofol n=111 Participants IV Propofol for induction and maintenance of anesthesia	Propofol Induction Sevoflurane Maintenance n=111 Participants Propofol bolus for IV induction and sevoflurane for maintenance of anesthesia
Time to Extubation	9.69 Minutes Standard Deviation 3.84	11.32 Minutes Standard Deviation 6.91	9.79 Minutes Standard Deviation 3.52

SECONDARY outcome

Timeframe: Every minute after anesthesia was stopped until orientation occurred

Time to orientation was measured from the time sevoflurane or propofol administration was stopped until orientation (able to state their name and date of birth).

Outcome measures

Measure	Sevoflurane n=112 Participants Inhalational sevoflurane for induction and maintenance of anesthesia	Propofol n=111 Participants IV Propofol for induction and maintenance of anesthesia	Propofol Induction Sevoflurane Maintenance n=111 Participants Propofol bolus for IV induction and sevoflurane for maintenance of anesthesia
Time to Orientation	13.97 Minutes Standard Deviation 6.73	17.64 Minutes Standard Deviation 12.45	14.95 Minutes Standard Deviation 6.39

Adverse Events

Sevoflurane

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Propofol

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Propofol Induction Sevoflurane Maintenance

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Sevoflurane n=112 participants at risk Inhalational induction and maintenance anesthesia with sevoflurane.	Propofol n=111 participants at risk Target controlled infusion anesthesia with propofol for induction and maintenance.	Propofol Induction Sevoflurane Maintenance n=111 participants at risk Propofol induction and sevoflurane maintenance anesthesia.
Cardiac disorders bradycardia	2.7% 3/112 • All adverse events were reported from the time study drug was administered until 30 days after the study drug treatment was completed. Serious adverse events were collected from the time the subject signed the informed consent form.	0.00% 0/111 • All adverse events were reported from the time study drug was administered until 30 days after the study drug treatment was completed. Serious adverse events were collected from the time the subject signed the informed consent form.	0.90% 1/111 • All adverse events were reported from the time study drug was administered until 30 days after the study drug treatment was completed. Serious adverse events were collected from the time the subject signed the informed consent form.
Investigations diastolic blood pressure decreased	0.00% 0/112 • All adverse events were reported from the time study drug was administered until 30 days after the study drug treatment was completed. Serious adverse events were collected from the time the subject signed the informed consent form.	0.00% 0/111 • All adverse events were reported from the time study drug was administered until 30 days after the study drug treatment was completed. Serious adverse events were collected from the time the subject signed the informed consent form.	0.90% 1/111 • All adverse events were reported from the time study drug was administered until 30 days after the study drug treatment was completed. Serious adverse events were collected from the time the subject signed the informed consent form.
Vascular disorders hypotension	2.7% 3/112 • All adverse events were reported from the time study drug was administered until 30 days after the study drug treatment was completed. Serious adverse events were collected from the time the subject signed the informed consent form.	1.8% 2/111 • All adverse events were reported from the time study drug was administered until 30 days after the study drug treatment was completed. Serious adverse events were collected from the time the subject signed the informed consent form.	1.8% 2/111 • All adverse events were reported from the time study drug was administered until 30 days after the study drug treatment was completed. Serious adverse events were collected from the time the subject signed the informed consent form.
Nervous system disorders Movement Disorder	0.00% 0/112 • All adverse events were reported from the time study drug was administered until 30 days after the study drug treatment was completed. Serious adverse events were collected from the time the subject signed the informed consent form.	0.90% 1/111 • All adverse events were reported from the time study drug was administered until 30 days after the study drug treatment was completed. Serious adverse events were collected from the time the subject signed the informed consent form.	0.00% 0/111 • All adverse events were reported from the time study drug was administered until 30 days after the study drug treatment was completed. Serious adverse events were collected from the time the subject signed the informed consent form.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/112 • All adverse events were reported from the time study drug was administered until 30 days after the study drug treatment was completed. Serious adverse events were collected from the time the subject signed the informed consent form.	0.90% 1/111 • All adverse events were reported from the time study drug was administered until 30 days after the study drug treatment was completed. Serious adverse events were collected from the time the subject signed the informed consent form.	0.00% 0/111 • All adverse events were reported from the time study drug was administered until 30 days after the study drug treatment was completed. Serious adverse events were collected from the time the subject signed the informed consent form.
Vascular disorders Hypertension	0.00% 0/112 • All adverse events were reported from the time study drug was administered until 30 days after the study drug treatment was completed. Serious adverse events were collected from the time the subject signed the informed consent form.	0.00% 0/111 • All adverse events were reported from the time study drug was administered until 30 days after the study drug treatment was completed. Serious adverse events were collected from the time the subject signed the informed consent form.	0.90% 1/111 • All adverse events were reported from the time study drug was administered until 30 days after the study drug treatment was completed. Serious adverse events were collected from the time the subject signed the informed consent form.

Additional Information

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Phone: 800-633-9110

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• Principal investigator is a sponsor employee Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
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