Remimazolam for Colonoscopy in IBD Patients
ConditionIBD (Inflammatory Bowel Disease)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-90
SponsorHumanitas Clinical and Research Center
About this trial
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
Eligibility criteria
Qualifiers
* Age ≥18 years
Diagnosis of IBD (CD or UC) for ≥6 months
Scheduled colonoscopy for clinical or surveillance purposes
Ability to provide informed consent
Disqualifiers
ASA class IV
Allergy to benzodiazepines, opioids, flumazenil, or naloxone
Severe COPD
Obstructive sleep apnea
Trial design
Treatments tested in this trial
- Intravenous remimazolam (5 mg initially, with optional 2.5 mg boluses) plus fentanyl (100 mcg) for procedural sedation.
- Intravenous midazolam (3 mg initially, with optional 3 mg boluses) plus fentanyl (100 mcg) for procedural sedation.
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov