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

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 in...

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Hauptverfasser: Fechner, Jörg (VerfasserIn) , El-Boghdadly, K. (VerfasserIn) , Spahn, Donat Rudolf (VerfasserIn) , Motsch, Johann (VerfasserIn) , Struys, M.M.R.F. (VerfasserIn) , Duranteau, O. (VerfasserIn) , Ganter, M.T. (VerfasserIn) , Richter, T. (VerfasserIn) , Hollmann, M.W. (VerfasserIn) , Rossaint, Rolf (VerfasserIn) , Bercker, Sven (VerfasserIn) , Rex, Steffen (VerfasserIn) , Drexler, Berthold (VerfasserIn) , Schippers, Frank (VerfasserIn) , Morley, A. (VerfasserIn) , Ihmsen, Harald (VerfasserIn) , Kochs, E. (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: 14 January 2024
In: Anaesthesia
Year: 2024, Jahrgang: 79, Heft: 4, Pages: 410-422
ISSN:1365-2044
DOI:10.1111/anae.16205
Online-Zugang:Verlag, kostenfrei, Volltext: https://doi.org/10.1111/anae.16205
Verlag, kostenfrei, Volltext: https://onlinelibrary.wiley.com/doi/abs/10.1111/anae.16205
Volltext
Verfasserangaben: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 and on behalf of the Surgery Under Remimazolam-Total IntraVenous Anaesthesia (SURE-TIVA) Trial Group
Beschreibung
Zusammenfassung: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.
Beschreibung:Gesehen am 26.03.2024
Beschreibung:Online Resource
ISSN:1365-2044
DOI:10.1111/anae.16205

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