- Remimazolam-based TIVA was noninferior to propofol-based TIVA for postoperative delirium within 5 days (risk difference 1.97 percentage points; one-sided P<0.001).
- Remimazolam reduced intraoperative hypotensive burden below MAP 65 mm Hg compared with propofol (median 0 vs 7.5 mm Hg·min; P<0.001).
- Emergence was faster with remimazolam, with more patients extubated in the operating room (85.2% vs 67.3%).
Br J Anaesth. 2026 Oct 29:S0007-0912(26)00742-7. doi: 10.1016/j.bja.2026.09.021. Online ahead of print.
ABSTRACT
BACKGROUND: Propofol-based total intravenous anaesthesia (TIVA) is commonly used in neurovascular surgery, in which intraoperative neurophysiological monitoring limits inhalation anaesthetic use. However, propofol causes hypotension, and prolonged infusions can delay emergence. Remimazolam, a benzodiazepine whose effects are reversible with flumazenil, has been associated with less intraoperative hypotension than propofol, but its use raises concerns about postoperative delirium (POD). We tested whether remimazolam-based TIVA is noninferior to propofol-based TIVA for POD.
METHODS: In this single-centre, double-blind, randomised noninferiority trial, adults undergoing elective intracranial aneurysm clipping, arteriovenous malformation resection, microvascular decompression, or superficial temporal artery-middle cerebral artery bypass received remimazolam-based TIVA with flumazenil reversal at emergence, or propofol-based TIVA, both with remifentanil. The primary outcome was the cumulative incidence of POD within 5 days, assessed twice daily with the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) or the 3-Minute Diagnostic Interview for CAM-defined delirium (3D-CAM). The prespecified noninferiority margin was 10 percentage points.
RESULTS: Among 686 patients in the modified intention-to-treat analysis, POD occurred in 44 of 344 (12.8%) with remimazolam and 37 of 342 (10.8%) with propofol (risk difference, 1.97 percentage points; 95% CI, -2.85 to 6.80; one-sided P<0.001 for noninferiority); per-protocol results were consistent. Hypotensive burden below a mean arterial pressure threshold of 65 mm Hg was lower in the remimazolam group (median, 0 vs 7.5 mm Hg min; P<0.001), and tracheal extubation in the operating room was more frequent (85.2% vs 67.3%).
CONCLUSIONS: Remimazolam-based TIVA met the prespecified criterion for noninferiority to propofol-based TIVA with respect to postoperative delirium after elective neurovascular surgery. Interpretation should take into account that the observed incidence of postoperative delirium was lower than anticipated when the noninferiority margin was defined.
CLINICAL TRIAL REGISTRATION: NCT06115031 (ClinicalTrials.gov).
PMID:42957499 | DOI:10.1016/j.bja.2026.09.021
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