Incidence of postoperative delirium and quality of recovery in older patients undergoing gastrectomy under general anaesthesia with remimazolam vs. propofol: a randomised non-inferiority study.

Abstract

INTRODUCTION Due to its haemodynamic stability and rapid recovery from anaesthesia, remimazolam is an attractive hypnotic drug for general anaesthesia in older patients. However, remimazolam must show non-inferiority in terms of the incidence of delirium and quality of postoperative recovery to be used as an alternative to propofol for maintenance of general anaesthesia. METHODS Patients aged ≥ 65 y scheduled to undergo gastrectomy were randomly allocated to maintenance of general anaesthesia with a remimazolam infusion (remimazolam group) or propofol target-controlled infusion (propofol group) in a 1:1 ratio. The primary outcome measure was the incidence of delirium within 72 h of surgery (assessed using the confusion assessment method). Secondary outcomes included the quality of recovery at 24 h postoperatively (assessed using the translated Korean version of the 15-item Quality of Recovery questionnaire) and the incidence of postoperative nausea, retching and vomiting. RESULTS Of 461 patients randomly allocated in the study, 432 were included in the analysis (216 in each group). The incidence of delirium was 17/216 (7.9%) in patients allocated to the remimazolam group and 17/216 (7.9%) in those allocated to the propofol group (unadjusted odds ratio 1.00, 95%CI 0.50-2.02, p = 1.000). Quality of recovery scores were also similar between groups at 24 h postoperatively (median (IQR [range]) 109 (102-115 [54-140]) vs. 109 (104-115 [70-137]) for the remimazolam and propofol groups, respectively (p = 0.627); unadjusted odds ratio -0.03, 95%CI -0.19-0.13). DISCUSSION Remimazolam can be used as an alternative to propofol in older patients undergoing gastrectomy from the perspective of the incidence of postoperative delirium and quality of recovery.