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NCT Number: NCT07161297

Remimazolam for Colonoscopy in IBD Patients

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

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Key information

Conditions

IBD (Inflammatory Bowel Disease) Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Patient satisfaction

    Time frame: Immediately post-procedure

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

Secondary outcomes

  1. Patient high satisfaction

    Time frame: Immediately post-procedure

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

  2. Incidence of treatment-emergent adverse events

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

    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

  3. Discharge readiness 10'

    Time frame: 10 minutes post-procedure

    Proportion of patients ready for discharge (PADSS ≥9)

  4. Dischatge readiness 20'

    Time frame: 20 minutes post-procedure

    Proportion of patients ready for discharge (PADSS ≥9)

  5. Maximum net benefit

    Time frame: 10 minutes post-procedure

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

Other outcomes

  1. Endoscopy metrics - cecal intubation rate

    Time frame: During procedure

    Percentage of procedures where the endoscope successfully reaches the cecum and can be visually confirmed by inspecting the appendiceal orifice

  2. Endoscopy metrics - cecal intubation time

    Time frame: During procedure

    Time from the insertion of the colonoscope tip into the anal verge until reaching the cecal base

Study contacts

Contact information is provided by the study sponsor or research team.

Cristina Alessandro Armuzzi, MD PhD

CONTACT

[email protected]

+393392529254

Cristina Bezzio

CONTACT

[email protected]

+393392529254

Sponsors and collaborators

Lead sponsor

Humanitas Clinical and Research Center

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 8, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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