1. Anaesthetic efficacy and postinduction hypotension with remimazolam compared with propofol: a multicentre randomised controlled trial.
- Author
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Fechner, J., El‐Boghdadly, K., Spahn, D. R., Motsch, J., Struys, M. M. R. F., Duranteau, O., Ganter, M. T., Richter, T., Hollmann, M. W., Rossaint, R., Bercker, S., Rex, S., Drexler, B., Schippers, F., Morley, A., Ihmsen, H., and Kochs, E.
- Subjects
INTRAVENOUS anesthesia ,RANDOMIZED controlled trials ,PROPOFOL ,ANESTHETICS ,HYPOTENSION ,ELECTIVE surgery - Abstract
Summary: 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. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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