Colonoscopy is central to IBD care but acceptance may be limited by anxiety and discomfort. Remimazolam, a short-acting benzodiazepine, could offer advantages over midazolam. We compared efficacy, safety, and recovery between remimazolam and midazolam in IBD patients undergoing colonoscopy.

Single-center, prospective, randomized trial of IBD patients scheduled for elective colonoscopy, allocated 1:1 to remimazolam or midazolam. Primary outcome: proportion of patients reporting at least “satisfied” immediately postprocedure (binary endpoint ≥“satisfied” vs <“satisfied”). Secondary outcomes: discharge readiness at 10 and 20 minutes (PADSS), adverse events (allergic reactions; hypotension; hypoxia defined as SpO₂ <90% requiring >4 L/min O₂; respiratory depression; bradycardia <60 bpm; nausea; vomiting; dizziness; headache; intra- vs post-procedural timing), and endoscopic performance outcomes We used a Bayesian framework. For the primary endpoint, non-inferiority of remimazolam versus midazolam was assessed with a prespecified margin of −10%. Posterior distributions and 95% credible intervals (CrI) were obtained via Monte Carlo sampling

A total of 216 patients were initially assessed for eligibility and assigned with an approximate ratio of 1:1 to receive either midazolam or remimazolam. Of these, 16 patients were excluded from the final analysis due to the following reasons: inadequate bowel preparation (n = 6), withdrawal of informed consent before the procedure (n = 5), and technical issues preventing completion of the colonoscopy or data recording (n = 5). The final study population consisted of 200 patients, equally distributed between the two treatment groups. Baseline demographic, clinical, and disease-related characteristics were well balanced between groups. Overall satisfaction was high and remimazolam was non-inferior to midazolam (96.4% vs 97.3%). “Very satisfied” responses were more frequent with remimazolam (62.2%, 95% CrI 55.4–72.5%) than midazolam (48.3%, 95% CrI 39.5–57.3%; posterior probability of superiority 99.3%). Discharge readiness favored remimazolam at 10 minutes (65.0%, 95% CrI 56.3–73.3% vs 27.5%, 95% CrI 19.9–35.8%) and 20 minutes (88.3%, 95% CrI 82.0–93.4% vs 64.2%, 95% CrI 55.4–72.5%). A personalized model suggested greater benefit from remimazolam among younger patients, females, and those with shorter disease duration. Adverse events were infrequent in both treatment groups and generally mild in severity. The most commonly reported event was transient hypotension, observed in 4% of patients receiving midazolam and 2% of those treated with remimazolam. Nausea occurred in 3% of midazolam-treated patients and 1% of those in the remimazolam group. No cases of hypoxemia were reported in either group. Only one patient (1%) in the midazolam group experienced a prolonged recovery time that delayed discharge beyond 60 minutes, whereas no such delays were observed with remimazolam

Remimazolam is a safe, effective alternative to midazolam for colonoscopy sedation in IBD, yielding higher patient satisfaction and markedly faster recovery. Personalized sedation strategies may enhance its clinical value