Status:
NOT_YET_RECRUITING
Remimazolam for Colonoscopy in IBD Patients
Lead Sponsor:
Humanitas Clinical and Research Center
Conditions:
IBD (Inflammatory Bowel Disease)
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
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 ulc...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Age ≥18 years
- Diagnosis of IBD (CD or UC) for ≥6 months
- Scheduled colonoscopy for clinical or surveillance purposes
- Ability to provide informed consent
- Exclusion Criteria
- ASA class IV
- Allergy to benzodiazepines, opioids, flumazenil, or naloxone
- Severe COPD
- Obstructive sleep apnea
- BMI \>35
- Pregnancy or lactation
- Prior multiple ileocolonic resections or subtotal colectomy
- Inability to complete questionnaires
Exclusion
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07161297
Start Date
September 1 2025
End Date
September 30 2025
Last Update
September 8 2025
Active Locations (1)
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1
Humanitas Research Hospital
Rozzano, Milano, Italy, 20089