CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 336 enrolled
Drug / intervention
Sevoflurane Inhalational Induction and Maintenance +2 moredrug
Likely dose
Propofol Target Controlled Infusion for Induction and Sevoflurane Inhalation for Maintenance 1.5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01191476
NCT01191476Phase 4Completed

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

Abbott·interventional·Posted Aug 30, 2010·Updated Jul 3, 2012

In Brief

A Phase 4 clinical trial evaluating Sevoflurane Inhalational Induction and Maintenance, Propofol Target Controlled Infusion for Induction and Maintenance, and 1 other intervention for Elective Laparoscopic Surgery. Completed, enrolled 336 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 30, 2010
Enrollment StartNov 1, 2010
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 15.8 years ago

Interventions

Sevoflurane Inhalational Induction and Maintenancedrug

Sevoflurane was administered at a concentration of 8% via vital capacity induction and sevoflurane 0.8-1.5 minimum alveolar concentration (MAC) with a rate of 1 L/min fresh gas flow for maintenance.

Propofol Target Controlled Infusion for Induction and Maintenancedrug

Propofol IV 4 ug/mL was administered with target controlled infusion (TCI) for induction and propofol 3 to 6 ug/mL was administered with TCI for maintenance.

Propofol Target Controlled Infusion for Induction and Sevoflurane Inhalation for Maintenancedrug

Propofol was administered as a bolus IV dose of 1.5 mg/kg for induction at a rate of 40 mg/10 seconds. During maintenance, a sevoflurane concentration of 0.8-1.5 minimal alveolar concentration (MAC) was administered at a rate of 1 L/min fresh gas flow.