Remimazolam for Colonoscopy in IBD Patients
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Patient satisfaction
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm 2 (Remimazolam + Fentanyl)
ARM 2: Participants receive intravenous remimazolam plus fentanyl for procedural sedation during colonoscopy
Intervention: Intravenous remimazolam (5 mg initially, with optional 2.5 mg boluses) plus fentanyl (100 mcg) for procedural sedation. (Drug)
Arm 1 (Midazolam + Fentanyl)
Arm Description: ARM 1: Participants receive intravenous midazolam plus fentanyl for procedural sedation during colonoscopy.
Intervention: Intravenous midazolam (3 mg initially, with optional 3 mg boluses) plus fentanyl (100 mcg) for procedural sedation. (Drug)
Outcomes
Primary Outcomes
Patient satisfaction
Time Frame: Immediately post-procedure
Proportion of patients reporting at least "satisfied" with sedation (Likert scale 1-4, 3 or 4 points)
Secondary Outcomes
- Discharge readiness 10'(10 minutes post-procedure)
- Patient high satisfaction(Immediately post-procedure)
- Maximum net benefit(10 minutes post-procedure)
- Incidence of treatment-emergent adverse events(Throughout the observation period (i.e., until discharge))
- Dischatge readiness 20'(20 minutes post-procedure)