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

Phase 4

Completed

• Conditions: Elective Laparoscopic Surgery
• Interventions: Drug: Propofol Target Controlled Infusion for Induction and Sevoflurane Inhalation for Maintenance; Drug: Sevoflurane Inhalational Induction and Maintenance; Drug: Propofol Target Controlled Infusion for Induction and Maintenance

• Registration Number: NCT01191476
• Lead Sponsor: Abbott

Brief Summary

This study is being performed to compare the cost of anesthetic techniques with sevoflurane (low fresh gas flow balanced anesthesia) versus propofol (target controlled infusion \[TCI\]) versus propofol induction and sevoflurane maintenance anesthesia in subjects undergoing elective laparoscopic surgery with predicted anesthesic use between 1 and 3 hour duration.

Detailed Description

Three hundred thirty-six subjects were enrolled in this study. Two subjects, one treated with propofol for induction and maintenance and one treated with propofol for induction and sevoflurane for maintenance are not included in the study participation since no information was available for these two subjects.

Study Timeline

• Study First Submitted: 2010-08-27
• Study First Submitted QC: 2010-08-27
• Study First Posted: 2010-08-30
• Study Start: 2010-11
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2012-05
• Results First Submitted: 2012-05-31
• Results First Submitted QC: 2012-05-31
• Last Update Submitted: 2012-05-31
• Results First Posted: 2012-07-03
• Last Update Posted: 2012-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 336

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol Induction and Sevoflurane Maintenance	Propofol Target Controlled Infusion for Induction and Sevoflurane Inhalation for Maintenance	Subjects received a bolus dose of propofol of 1.5 mg/kg administered for IV induction followed by sevoflurane at 0.8-1.5 MAC for maintenance anesthesia.
Sevoflurane	Sevoflurane Inhalational Induction and Maintenance	Subjects received sevoflurane, a inhalational (volatile) anesthetic, which was administered for induction and maintenance of general anesthesia. Inhalational induction was induced via vital capacity induction at 8% and maintained at 0.8-1.5 minimum alveolar concentration (MAC).
Propofol	Propofol Target Controlled Infusion for Induction and Maintenance	Subjects received propofol, an intravenous (IV) anesthetic, which was administered for induction and maintenance of general anesthesia.

Primary Outcome Measures

Name	Time	Method
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	Anesthetic Duration between 1 to 3 Hours	\[Cost of VIMA = unit price of sevoflurane X used volume of sevoflurane\]; \[Cost of TIVA = unit price of propofol X total volume of propofol in the syringe\]; \[Cost of Propofol Induction and Sevoflurane Maintenance = unit price of propofol X total volume of propofol in the syringe + unit price of sevoflurane X volume of sevoflurane in the syringe\].; The total volume of propofol in the syringe was calculated, even if all the anesthetic was not used, because it could not be reused.

Secondary Outcome Measures

Name	Time	Method
Time to Loss of Consciousness	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.
Time to Eye Opening	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.
Time to Extubation	Every minute after anesthesia was stopped until extubation occurred	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.
Time to Orientation	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).

Trial Locations

Locations (4)

Site Reference ID/Investigator# 41983; 🇨🇳 Beijing, China

Site Reference ID/Investigator# 41932; 🇨🇳 Chengdu, China

Site Reference ID/Investigator# 41984; 🇨🇳 Shanghai, China

Site Reference ID/Investigator# 41985; 🇨🇳 Guangzhou City, China