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Anaesthetic Efficacy and Postinduction Hypotension with Remimazolam Compared with Propofol: a Multicentre Randomised Controlled Trial

J. Fechner,K. El-Boghdadly,D. R. Spahn, J. Motsch,M. M. R. F. Struys, O. Duranteau,M. T. Ganter, T. Richter,M. W. Hollmann, R. Rossaint,S. Bercker,S. Rex,B. Drexler, F. Schippers, A. Morley,H. Ihmsen, E. Kochs

ANAESTHESIA(2024)

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摘要
Remimazolam, a short-acting benzodiazepine, may be used for induction and maintenance of total intravenous anaesthesia, but its role in the management of patients with multiple comorbidities remains unclear. In this phase 3 randomised controlled trial, we compared the anaesthetic efficacy and the incidence of postinduction hypotension during total intravenous anaesthesia with remimazolam vs. propofol. A total of 365 patients (ASA physical status 3 or 4) scheduled for elective surgery were assigned randomly to receive total intravenous anaesthesia with remimazolam (n = 270) or propofol (n = 95). Primary outcome was anaesthetic effect, quantified as the percentage of time with Narcotrend (R) Index values <= 60, during surgery (skin incision to last skin suture), with a non-inferiority margin of -10%. Secondary outcome was the incidence of postinduction hypotensive events. Mean (SD) percentage of time with Narcotrend Index values <= 60 during surgery across all patients receiving remimazolam (93% (20.7)) was non-inferior to propofol (99% (4.2)), mean difference (97.5%CI) -6.28% (-8.89-infinite); p = 0.003. Mean (SD) number of postinduction hypotension events was 62 (38.1) and 71 (41.1) for patients allocated to the remimazolam and propofol groups, respectively; p = 0.015. Noradrenaline administration events (requirement for a bolus and/or infusion) were also lower in patients allocated to remimazolam compared with propofol (14 (13.5) vs. 20 (14.6), respectively; p < 0.001). In conclusion, in patients who were ASA physical status 3 or 4, the anaesthetic effect of remimazolam was non-inferior to propofol.
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关键词
hypotension,propofol,remimazolam,total intravenous anaesthesia
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