Anaesthetic efficacy and postinduction hypotension with remimazolam compared with propofol: a multicentre randomised controlled trial.

Fechner J, El-Boghdadly K, Spahn DR, Motsch J, Struys MM, Duranteau O, Ganter MT, Richter T, Hollmann MW, Rossaint R, Bercker S, Rex S, Drexler B, Schippers F, Morley A, Ihmsen H, Kochs E (2024)


Publication Type: Journal article

Publication year: 2024

Journal

Book Volume: 79

Pages Range: 410-422

Journal Issue: 4

DOI: 10.1111/anae.16205

Abstract

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® 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.

How to cite

APA:

Fechner, J., El-Boghdadly, K., Spahn, D.R., Motsch, J., Struys, M.M., Duranteau, O.,... Kochs, E. (2024). Anaesthetic efficacy and postinduction hypotension with remimazolam compared with propofol: a multicentre randomised controlled trial. Anaesthesia, 79(4), 410-422. https://dx.doi.org/10.1111/anae.16205

MLA:

Fechner, J., et al. "Anaesthetic efficacy and postinduction hypotension with remimazolam compared with propofol: a multicentre randomised controlled trial." Anaesthesia 79.4 (2024): 410-422.

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