Remimazolam for Colonoscopy in IBD Patients

Phase 4Not Yet RecruitingNCT07161297

Humanitas Clinical and Research Center200 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

IBD (Inflammatory Bowel Disease)

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

* 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

Outcomes

Primary Outcomes

Patient satisfaction

Proportion of patients reporting at least "satisfied" with sedation (Likert scale 1-4, 3 or 4 points)

Time frame: Immediately post-procedure

Secondary Outcomes

Patient high satisfaction

Proportion reporting "very satisfied" (Likert scale 1-4, 4 points)

Time frame: Immediately post-procedure

Incidence of treatment-emergent adverse events

Proportion of patients experiencing any of the following adverse events (occurring after the administration of the study drug): * Desaturation: peripheral oxygen saturation (SpO₂) below 90% * Tachycardia: heart rate greater than 100 bpm * Bradycardia: heart rate less than 50 bpm * Hypotension: systolic blood pressure below 90 mmHg

Time frame: Throughout the observation period (i.e., until discharge)

Discharge readiness 10'

Proportion of patients ready for discharge (PADSS ≥9)

Time frame: 10 minutes post-procedure

Dischatge readiness 20'

Proportion of patients ready for discharge (PADSS ≥9)

Time frame: 20 minutes post-procedure

Maximum net benefit

Proportion of patients reportinng "very satisfied" with sedation (Likert scale 1-4, 4 points) + ready for discharge (PADSS ≥9)

Time frame: 10 minutes post-procedure

Central Contacts

Cristina Alessandro Armuzzi, MD PhD

CONTACT

+393392529254 alessandro.armuzzi@hunimed.eu

Cristina Bezzio