Effects of etomidate versus propofol for total intravenous anaesthesia on postoperative quality of recovery in patients undergoing day-case laparoscopic cholecystectomy: protocol for a multicentre, randomised controlled non-inferiority trial.

Abstract

The choice of anaesthetic agents may influence specific aspects of postoperative recovery, such as haemodynamic stability, recovery times and the incidence of adverse events, in patients undergoing day-case laparoscopic cholecystectomy. Propofol is widely used in total intravenous anaesthesia (TIVA) for its favourable recovery profile, while etomidate, valued for its haemodynamic stability, is less commonly used due to concerns about adrenal suppression. This study aims to compare etomidate-based and propofol-based TIVA on postoperative quality of recovery in patients undergoing day-case laparoscopic cholecystectomy, hypothesising that etomidate is non-inferior to propofol. A multicentre, double-blind, randomised controlled non-inferiority trial was conducted to compare the effects of etomidate vs propofol for TIVA on postoperative quality of recovery in patients undergoing day-case laparoscopic cholecystectomy. A total of at least 336 participants were enrolled and randomly assigned to either the etomidate or propofol group in a 1:1 ratio, stratified by site. The primary outcome was quality of recovery on postoperative day 1, quantified by the Quality of Recovery-15 questionnaire. Non-inferiority between the groups was determined using a margin of -6 points and a 95% CI. Secondary outcomes included perioperative haemodynamic stability, recovery times (eg, response to verbal commands, time to extubation and duration of postanaesthesia care unit stay), postoperative complications (eg, hypoxaemia, nausea/vomiting, delirium) and patient-reported outcomes such as pain, satisfaction and quality of sleep. Long-term outcomes included quality of life at 6 and 12 months, assessed using the 36-Item Short Form Health Survey. This study was approved by the Ethics Committee of Nanjing University Medical School, Drum Tower Hospital (No. 2024-371-04) and registered in the Chinese Clinical Trial Registry. ChiCTR2400087413.