Abstract
OBJECTIVE: To evaluate the comparative efficacy and safety of remimazolam vs. established sedatives (dexmedetomidine, propofol, midazolam) for sedation during bronchoscopy. METHODS: A systematic review and meta-analysis of randomized controlled trials (RCTs) was conducted according to PRISMA guidelines and Cochrane Handbook recommendations (PROSPERO CRD420251071986). Databases (EMBASE, PubMed, Scopus, Cochrane Central, Web of Science) were searched from inception to May 14, 2025. Included studies were RCTs comparing intravenous remimazolam to comparator sedatives in adults (≥18 years) undergoing bronchoscopy. Primary outcome was procedural success rate (completion without rescue sedation). Secondary outcomes included onset time, wake-up time, procedure duration, patient satisfaction, and adverse events (hypotension, hypoxemia, tachycardia, bradycardia, hypertension). Risk of bias was assessed using RoB 2. Data were pooled using random-effects models, reporting mean differences (MD) or odds ratios (OR) with 95% confidence intervals (CI). RESULTS: 13 RCTs (n = 2,002 patients) were included. Remimazolam demonstrated: Procedural success: Significantly higher success rates vs. dexmedetomidine (OR 2.87, 95% CI [1.13-7.29], P = 0.03; I(2) = 62%) and vs. midazolam (OR 3.65, 95% CI [1.40-9.49], P = 0.008; absolute rates 77.1% vs. 3.6%). Comparable success rates to propofol (OR 0.55, 95% CI [0.11-2.61], P = 0.45; rates ~98% each). Onset/Recovery: Faster onset vs. dexmedetomidine (MD -2.01 min, 95% CI [-2.08 to -1.93], P < 0.001; I(2) = 0%). Shorter wake-up time vs. dexmedetomidine (MD -1.84 min, 95% CI [-3.31 to -0.37], P = 0.01) and vs. midazolam (MD -4.72 min, 95% CI [-8.05 to -1.39], P = 0.005). Comparisons with propofol were inconclusive due to heterogeneity. Safety: Significantly lower risk of hypotension vs. propofol (OR 0.35, 95% CI [0.23-0.55], P < 0.00001) and hypoxemia vs. dexmedetomidine (OR 0.41, 95% CI [0.18-0.96], P = 0.04). Significantly higher risk of tachycardia vs. dexmedetomidine (OR 3.01, 95% CI [1.37-6.60], P = 0.006). No significant safety differences vs. midazolam. Patient satisfaction was equivalent to propofol. CONCLUSION: Remimazolam is a highly effective and safe sedative for bronchoscopy. It offers superior procedural success and faster recovery compared to dexmedetomidine and midazolam, while matching the high success rate of propofol. Its key safety advantage is significantly reduced hypotension risk compared to propofol, making it particularly suitable for vulnerable patients. Remimazolam represents a valuable addition to sedation options for this procedure.