Comparing propofol anaesthesia guided by Bispectral Index monitoring and frontal EEG wave analysis with standard monitoring in laparoscopic surgery: protocol for the ‘EEG in General Anaesthesia - More Than Only a Bispectral Index’ Trial, a multicentre, double-blind, randomised controlled trial

Abstract

IntroductionThe use of Bispectral Index (BIS) monitors for assessing depth of sedation has led to a reduction in both the incidence of awareness and anaesthetic consumption in total intravenous anaesthesia. However, these monitors are vulnerable to artefacts. In addition to the processed number, the raw frontal electroencephalogram (EEG) can be displayed as a curve on the same monitor. Anaesthesia practitioners can learn to interpret the EEG in a short tutorial and may be quicker and more accurate thanBIS in assessing anaesthesia depth by recognising EEG patterns. We hypothesise that quality of recovery (QoR) in patients undergoing laparoscopic surgery is better, if propofol is titrated by anaesthesia practitioners able to interpret the EEG.Methods and analysisThis is a multicentre, double-blind (patients and outcome assessors) randomised controlled trial taking place in four Swiss hospitals. Patients aged 18 years or older undergoing laparoscopic procedures with general anaesthesia using propofol and anaesthesia practitioners with more than 2 years experience will be eligible. The primary study outcome is the difference in QoR 24 hours after surgery. Secondary outcomes are propofol consumption, incidence of postoperative nausea and vomiting (PONV) and postoperative delirium.QoR and propofol consumption are compared between both groups using a two-sample t-test. Fisher’s exact test is used to compare the incidences of PONV and delirium. A total of 200 anaesthesia practitioners (and 200 patients) are required to have an 80% chance of detecting the minimum relevant difference for the QoR-15 as significant at the 5% level assuming a SD of 20.Ethics and disseminationEthical approval has been obtained from all responsible ethics committees (lead committee: Ethikkommission Nordwest- und Zentralschweiz, 16 January 2021). The findings of the trial will be published in a peer-reviewed journal, presented at international conferences, and may lead to a change in titrating propofol in clinical practice.Trial registration numberwww.clinicaltrials.gov:NCT04105660