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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| Main Authors: | , , , , , , , , , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
14 January 2024
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| In: |
Anaesthesia
Year: 2024, Volume: 79, Issue: 4, Pages: 410-422 |
| ISSN: | 1365-2044 |
| DOI: | 10.1111/anae.16205 |
| Online Access: | Verlag, kostenfrei, Volltext: https://doi.org/10.1111/anae.16205 Verlag, kostenfrei, Volltext: https://onlinelibrary.wiley.com/doi/abs/10.1111/anae.16205 
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| Author Notes: | 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 |
| 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. |
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| Item Description: | Gesehen am 26.03.2024 |
| Physical Description: | Online Resource |
| ISSN: | 1365-2044 |
| DOI: | 10.1111/anae.16205 |