Efficacy and safety of monotherapy remimazolam compared to propofol for sedation in gastrointestinal endoscopic procedures: a systematic review and meta-analysis

Aims Remimazolam, an ultrashort-acting benzodiazepine, is a promising sedative in the armamentarium for healthcare professionals who do not have access to non-anesthesiologist-administered propofol sedation. We aimed to evaluate the efficacy and safety of remimazolam compared to propofol as monotherapy for sedation in adults undergoing gastrointestinal endoscopic procedures. Methods A systematic review across MEDLINE and Cochrane Central Register for RCTs was performed, evaluating the efficacy and safety of sedation with monotherapy remimazolam compared to propofol for sedation in GI endoscopic procedures, from 01.01.2019 to 31.07.2024. The primary outcome was the total adverse events rate, while sedation induction time, overall procedural time, sedation success, and patient satisfaction comprised the secondary outcomes. Pairwise meta-analyses were undertaken to present the effect size on study outcomes as either Risk Ratio (RR) or Mean Difference (MD) with 95% confidence interval (CI). We also performed sensitivity analyses by type of adverse event rate (hypotension, bradycardia, respiratory). The quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Results Fourteen RCTs involving 3158 patients (remimazolam 1587, propofol 1571) were included. Compared to propofol, monotherapy with remimazolam was associated with a significantly lower total adverse event rate [RR 0.66, 95% CI (0.56 – 0.78), I 2 =73%]. This effect was consistent for hypotension [RR 0.40, 95% CI (0.29 – 0.54), I 2 =75%], bradycardia episodes [RR 0.46 95% CI (0.32 – 0.67, I 2 =0%] as well as respiratory adverse events rate [RR 0.44, 95% CI (0.27-0.74), I 2 =42%]; there was low confidence in estimates. Remimazolam administration resulted also in a shorter sedation induction time [MD -0.41, 95% CI (-0.70 – 0.12), I 2 =97%]. On further analysis, procedural time, sedation success, and patient satisfaction were similar between the two medication treatments [MD 0.69, 95% CI (-0.74-2.13); I 2 =54%; RR 0.99, 95% CI (0.90-1.09), I 2 =98% and MD 0.77, 95% CI (-0.22-1.76), I 2 =55%, respectively]. Certainty of evidence was low. Conclusions Remimazolam monotherapy displays better safety profile with clinically similar efficacy when compared to propofol monotherapy for sedation in gastrointestinal endoscopic procedures. Publication History Article published online: 05 June 2026 © 2026. European Society of Gastrointestinal Endoscopy. All rights reserved. Georg Thieme Verlag KG Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany