Clinical Trial

Remimazolam for Colonoscopy in IBD Patients

Not Yet Recruiting Phase 4
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to compare two sedation regimens-remimazolam and midazolam-for colonoscopy in adult patients with inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis. The main questions it aims to answer are: * Does remimazolam provide patient satisfaction that is non-inferior to midazolam during colonoscopy? * Does remimazolam allow faster recovery and discharge readiness compared to midazolam? Researchers will compare sedation with remimazolam plus fentanyl to sedation with midazolam plus fentanyl to see if remimazolam improves patient experience and procedural efficiency. Participants will: * Receive either remimazolam or midazolam, each combined with fentanyl, during their scheduled colonoscopy * Complete a short questionnaire to rate their satisfaction after the procedure * Be assessed for recovery using a standardized discharge score at 10 and 20 minutes after the procedure
Trial Details
NCT Number NCT07161297
Lead Sponsor Humanitas Clinical and Research Center
Conditions IBD (Inflammatory Bowel Disease)
Enrollment 200 participants
Start Date 2025-09-01
Primary Completion 2025-09-07 (estimated)
Study Completion 2025-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-09-08