Remimazolam for Colonoscopy in IBD Patients

NCT07161297 | Not Yet Recruiting Phase 4

• 1 other identifier: IBD-REMI 2223386_1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

IBD (Inflammatory Bowel Disease)

Keywords

Inflammatory bowel disease (IBD); Remimazolam; Midazolam

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction

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

  Immediately post-procedure

Secondary Outcomes (5)

• Patient high satisfaction

  Immediately post-procedure

• Incidence of treatment-emergent adverse events

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

• Discharge readiness 10'

  10 minutes post-procedure

• Dischatge readiness 20'

  20 minutes post-procedure

• Maximum net benefit

  10 minutes post-procedure

Other Outcomes (2)

• Endoscopy metrics - cecal intubation rate

  During procedure

• Endoscopy metrics - cecal intubation time

  During procedure

Study Arms (2)

Arm 2 (Remimazolam + Fentanyl)

ACTIVE COMPARATOR

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

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

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

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

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.

Arm 2 (Remimazolam + Fentanyl)

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.

Arm 1 (Midazolam + Fentanyl)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Diagnosis of IBD (CD or UC) for ≥6 months
• Scheduled colonoscopy for clinical or surveillance purposes
• Ability to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Humanitas Clinical and Research Center: lead

Study Sites (1)

Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

Location

Related Links

• Requests should be submitted to: ibd@humanitas.it Subject: REMI-IBD IPD

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Cristina Alessandro Armuzzi, MD PhD

CONTACT

+393392529254; alessandro.armuzzi@hunimed.eu

Cristina Bezzio

CONTACT

+393392529254; bezzioc@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were assigned to sedation with either remimazolam or midazolam based on a pragmatic, time-based allocation schedule (i.e., all procedures during a given week used the same sedation regimen). This approach was chosen to ensure feasibility and avoid operator or patient selection bias. No individual-level randomization was performed.

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: September 8, 2025
• Study Start: September 1, 2025
• Primary Completion: September 7, 2025
• Study Completion: September 30, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: IPD will be made available within 6 months after publication of the main results and will remain available for up to 1 year thereafter.
• Access Criteria: Qualified researchers affiliated with academic institutions, healthcare organizations, or regulatory agencies will be able to request access to the de-identified individual participant data (IPD), including demographic variables, treatment allocation, sedation response, recovery scores, adverse events, and primary/secondary outcomes. Supporting documents such as the study protocol and statistical analysis plan (SAP) will also be available. Access will be granted upon submission and approval of a written data request, which must include a brief research proposal and data use rationale. A data-sharing agreement must be signed prior to access. Data will be shared securely via encrypted files or institutional data-sharing platforms approved by the sponsor institution.

Locations

IT (1)