Comparative efficacy and safety of remimazolam vs. dexmedetomidine: A systematic review and meta-analysis.

Sedation is a critical component of modern anesthesia and procedural medicine, particularly outside the operating room. Dexmedetomidine and remimazolam have emerged as prominent sedatives due to their unique pharmacological profiles. However, the comparative efficacy and safety of these agents remain incompletely understood, especially regarding recovery times and adverse events. In the present study, a systematic review and meta-analysis as performed following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A comprehensive literature search was conducted across PubMed, Cochrane Library and Scopus from inception until March 2025. The eligible studies compared the sedation efficacy, safety and recovery time of the dexmedetomidine group with the remimazolam group. Data extraction was independently conducted by two reviewers using a standardized data collection form. The methodological quality of observational studies was assessed using the Risk of Bias in Non-randomized Studies-of Interventions (ROBINS-I) tool, while randomized controlled trials (RCTs) were evaluated using the Cochrane Risk of Bias 2.0 (RoB 2.0) tool. Meta-analyses were conducted using random-effects models, and heterogeneity was evaluated through prediction interval analysis and sensitivity testing. A total of 9 studies were included, 4 of which were RCTs and judged to have low risk of bias across all domains. The remaining 5 observational studies, with most rated as having moderate risk of bias and 1 study rated as serious due to confounding and outcome measurement concerns. The forest plot analysis revealed that there was no statistically significant difference in the sedation efficacy between the dexmedetomidine group and the remimazolam group [standardized mean difference (SMD), 0.049; 95% confidence interval (CI), -0.101 to 0.198; P=0.523]. However, the remimazolam group consistently demonstrated significantly shorter full alertness times compared with the exmedetomidine group (SMDs ranging from -0.511 to -1.852, all P<0.001). There was no significant difference in the overall risk of adverse events between the two groups [odds ratio (OR), 1.509; 95% CI, 0.246-9.153; P=0.654]; however, the subgroup analysis showed that the risk of arrhythmia in the dexmedetomidine group was significantly higher than that in the remimazolam group (OR, 2.152; 95% CI, 1.158-3.999; P=0.015). In conclusion, both dexmedetomidine and remimazolam achieved similar sedation success rates, indicating no significant difference in procedural efficacy. However, remimazolam was associated with significantly faster recovery times and a lower risk of arrhythmia, making it particularly attractive for short-duration or outpatient procedures where rapid emergence and hemodynamic stability are prioritized.