Real‐World Evaluation of Remimazolam for Sedation During Gastrointestinal Endoscopy: Efficacy, Safety, and Risk Factors

ABSTRACT Background and Aim Remimazolam is a benzodiazepine receptor agonist intravenous anesthetic. This study aimed to evaluate the efficacy and safety of remimazolam for sedation during gastrointestinal endoscopy using real‐world clinical data. Methods This retrospective observational study included 352 patients who underwent esophagogastroduodenoscopy or colonoscopy sedated with remimazolam between January and February 2024 at our institution. Outcomes included the incidence of awakening during procedures, the sedation completion rate, and the incidence and severity of adverse events. Multivariate logistic regression analyses identified factors associated with hypoxia and hypotension. Results Median patient age was 67 years (IQR: 58–74), and 62.2% were male. Median initial and additional doses were 3 (IQR: 2–3 mg) and 1 mg (IQR: 0–2 mg). Awakening occurred in 19.0% of patients. The sedation completion rate was 100%. Adverse events included hypotension (7.8%), hypoxia (13.1%), and bradycardia (4.0%), and no serious adverse events were observed. The only risk factor for hypoxia was advanced age (Odds ratio 1.04, 95% confidence interval: 1.01–1.08, p = 0.03), and the dose of remimazolam itself was not an independent risk factor for either hypoxia or hypotension. Conclusions Remimazolam usage for gastrointestinal endoscopic sedation showed a favorable safety profile. Advanced age was associated with an increased risk of hypoxia, suggesting that careful monitoring and individualized sedation protocols are especially necessary for elderly patients. On the other hand, there are still issues regarding the duration of sedation. During long procedures, it is necessary to frequently check the depth of sedation to avoid undersedation.