A Prospective, Randomized, Open-label Multicenter Study Comparing the Pharmaceutical Economics and Effectiveness of Sevoflurane With Low Fresh Gas Flow Balanced Anesthesia, Propofol Target Controlled Infusion Anesthesia and Propofol Induction Sevoflurane Maintenance Anesthesia in Laparoscopic Surgeries in China
Overview
- Phase
- Phase 4
- Intervention
- Sevoflurane Inhalational Induction and Maintenance
- Conditions
- Elective Laparoscopic Surgery
- Sponsor
- Abbott
- Enrollment
- 336
- Locations
- 4
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Sevoflurane
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).
Intervention: Sevoflurane Inhalational Induction and Maintenance
Propofol
Subjects received propofol, an intravenous (IV) anesthetic, which was administered for induction and maintenance of general anesthesia.
Intervention: Propofol Target Controlled Infusion for Induction and Maintenance
Propofol Induction and Sevoflurane 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.
Intervention: Propofol Target Controlled Infusion for Induction and Sevoflurane Inhalation for Maintenance
Outcomes
Primary Outcomes
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
Time Frame: 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 Outcomes
- Time to Loss of Consciousness(Up to 10 minutes)
- Time to Eye Opening(Every minute after anesthesia was stopped until the subjects' eyes opened)
- Time to Extubation(Every minute after anesthesia was stopped until extubation occurred)
- Time to Orientation(Every minute after anesthesia was stopped until orientation occurred)