Remimazolam for Colonoscopy in IBD Patients
Phase 4 · Testing Intravenous remimazolam (5 mg initially, with optional 2.5 mg boluses) plus fentanyl (100… · 1 site · Humanitas Clinical and Research Center
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Intravenous remimazolam (5 mg initially, with optional 2.5 mg boluses) plus fentanyl (100 mcg) for procedural sedation. (a drug) and Intravenous midazolam (3 mg initially, with optional 3 mg boluses) plus fentanyl (100 mcg) for procedural sedation. (a drug) as a possible treatment. Condition(s) listed: IBD (Inflammatory Bowel Disease).
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.
Who can join
- Ages 18 to 90
- Any sex
Some of the main requirements, copied from the record:
- Inclusion Criteria
- Age ≥18 years
- Diagnosis of IBD (CD or UC) for ≥6 months
Plus 11 more requirement(s). Only the trial team can confirm whether you qualify.
What's involved
- About 200 participants are expected to take part.
- Start date: 2025-09-01 (planned).
- Main results expected around 2025-09-07 (estimate from the record).
- 1 study site listed in Italy.
Main thing being measured
- Patient satisfaction (Immediately post-procedure)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | IBD (Inflammatory Bowel Disease) |
| Lead sponsor | Humanitas Clinical and Research Center |
| Enrollment | 200 (estimated) |
| Start date | 2025-09-01 |
| Primary completion (est.) | 2025-09-07 |
| First posted | 2025-09-08 |
| Last updated | 2025-09-08 |
| Official title | Remimazolam for Colonoscopy in IBD Patients |
| ClinicalTrials.gov ID | NCT07161297 |
Interventions
- Intravenous remimazolam (5 mg initially, with optional 2.5 mg boluses) plus fentanyl (100 mcg) for procedural sedation. (Drug)
\- Remimazolam + Fentanyl IV fentanyl 100 mcg is given first, followed after 1 minute by IV remimazolam 5 mg over 1 minute. Additional 2.5 mg boluses may be given every 2 minutes as needed. Colonoscopy starts 1 minute after sedation. Vital signs are monitored throughout. - Intravenous midazolam (3 mg initially, with optional 3 mg boluses) plus fentanyl (100 mcg) for procedural sedation. (Drug)
\- Midazolam + Fentanyl (≤1000 caratteri) IV fentanyl 100 mcg is given first, followed after 1 minute by IV midazolam 3 mg over 1 minute. Additional midazolam may be administered based on clinical judgment. Colonoscopy starts 1 minute after sedation. Vital signs are monitored throughout.
Full eligibility criteria (from the record)
* 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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Humanitas Research Hospital | Rozzano, Milano | Italy |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.