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Clinical Trials in Italy / NCT07161297
Starting soon Phase 4

Remimazolam for Colonoscopy in IBD Patients

NCT07161297 · tracked via the Priya Life Science Italy tracker
Sponsor
Humanitas Clinical and Research Center
Phase
Phase 4
Started
2025-09-01
Last updated
2025-09-08

Condition(s) studied

IBD (Inflammatory Bowel Disease)

Investigational drug(s) / intervention(s)

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. →

Intravenous remimazolam (5 mg initially, with optional 2.5 mg boluses) plus fentanyl (100 mcg) for procedural sedation.: \- 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.: \- 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.

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
* 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Humanitas Research Hospital Rozzano Milano

More Humanitas Clinical and Research Center trials in Italy

"Mini Fluid Challenge Assessment: a Comparison Among Three Hemodynamic Tools" Starting soon
The PODIUM Study - a Three-arm Comparison of Target Therapies After Anti-TNFα in Ulcerative Colitis Recruiting

Other trials for the same condition

MICI-BIO: Study on Patient With Chronic Inflammatory Bowel Disease Recruiting
Specimen and Data Collection for a Novel Biomarker Combination for the Differential Diagnosis of Inflammatory Bowel Disease and Irritable Bowel Syndrome. Enrolling by invitation
Ex Vivo Comparison Of Combination Versus Single Therapeutic Pathway Inhibition In Human Intestinal Mucosa From Patients With Inflammatory Bowel Disease Starting soon
Microbiota: Its Role in Chronic Inflammation, IDB and Risk of Colorectal Cancer. Evaluation of a Predictive Prognostic Model With Therapeutic Implications Active, not recruiting
Sequencing in Inflammatory Bowel Diseases (IBD) Therapy: "the Latium Net". Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07161297 on ClinicalTrials.gov ↗ ← All trials in Italy