Abstract / Summary
Remimazolam, an short-acting benzodiazepine, is increasingly used as an alternative to propofol for sedation in mechanically ventilated critically ill patients; however, evidence regarding its comparative efficacy and safety remains inconsistent. We conducted a systematic review and meta-analysis to compare the clinical outcomes of remimazolam and propofol for sedation in the intensive care unit (ICU). Ovid MEDLINE, Embase, Web of Science, CINAHL, the Cochrane Library, ClinicalTrials.gov, and the International Clinical Trials Registry Platform (ICTRP) were searched from inception to August 22, 2026. We included randomized clinical trials comparing remimazolam with propofol for sedation in mechanically ventilated critically ill adults. Primary outcomes were sedation efficacy (sedation success rate, proportion of time within target sedation range, and rescue sedation use) and clinical outcomes (time to awakening, the 24 h extubation rate, mechanical ventilation duration, ICU length of stay, ventilator-free days, delirium, mortality, and adverse events). Data were pooled using random-effects models. Nine randomized clinical trials comprising 955 mechanically ventilated critically ill adults were included. Remimazolam and propofol showed no significant differences in sedation success rate (odds ratio = 1.50, 95% CI, 0.01 to 153.08), proportion of time within the target sedation range (mean difference 0.32, 95% CI -1.01 to 1.65), need for rescue sedation (odds ratio = 1.13, 95% CI, 0.52 to 2.47). ICU length of stay was significantly shorter with propofol (mean difference, 0.54 days; 95% CI, 0.03 to 1.05). No significant differences were found in time to awakening, duration of mechanical ventilation, the 24 h extubation rate, ventilator-free days, delirium incidence, or ICU and 28 day mortality. There was no statistically significant difference in the incidence of adverse events between groups. In critically ill patients receiving mechanical ventilation, no definitive evidence was found for differences between remimazolam and propofol in terms of sedative efficacy, clinical outcomes, or the incidence of adverse events; however, propofol was associated with a shorter ICU length of stay. These findings suggest that remimazolam may represent an alternative to propofol for light-to-moderate sedation, although the certainty of the available evidence remains limited. PROSPERO CRD420261443375.