Remimazolam for Colonoscopy in IBD Patients

Humanitas Clinical and Research Center

Status and phase: Not yet enrolling; Phase 4

Conditions: IBD (Inflammatory Bowel Disease)

Treatments: Drug: Intravenous remimazolam (5 mg initially, with optional 2.5 mg boluses) plus fentanyl (100 mcg) for procedural sedation.; Drug: Intravenous midazolam (3 mg initially, with optional 3 mg boluses) plus fentanyl (100 mcg) for procedural sedation.

Study type: Interventional

Funder types: Other

Identifiers

NCT07161297

IBD-REMI 2223386_1

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Arm 2 (Remimazolam + Fentanyl)

Active Comparator group

Description:

ARM 2: Participants receive intravenous remimazolam plus fentanyl for procedural sedation during colonoscopy

Treatment:

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

Arm 1 (Midazolam + Fentanyl)

Active Comparator group

Description:

Arm Description: ARM 1: Participants receive intravenous midazolam plus fentanyl for procedural sedation during colonoscopy.

Treatment:

Drug: Intravenous midazolam (3 mg initially, with optional 3 mg boluses) plus fentanyl (100 mcg) for procedural sedation.