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Remimazolam for Colonoscopy in IBD Patients

ConditionIBD (Inflammatory Bowel Disease)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-90
SponsorHumanitas Clinical and Research Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

* Age ≥18 years

Diagnosis of IBD (CD or UC) for ≥6 months

Scheduled colonoscopy for clinical or surveillance purposes

Ability to provide informed consent

Disqualifiers

ASA class IV

Allergy to benzodiazepines, opioids, flumazenil, or naloxone

Severe COPD

Obstructive sleep apnea

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Arm 2 (Remimazolam + Fentanyl)Active comparator 1 intervention
Group B: Arm 1 (Midazolam + Fentanyl)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

Patient high satisfaction

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

Time frame
Immediately post-procedure
2

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)
3

Discharge readiness 10'

Proportion of patients ready for discharge (PADSS ≥9)

Time frame
10 minutes post-procedure
4

Dischatge readiness 20'

Proportion of patients ready for discharge (PADSS ≥9)

Time frame
20 minutes post-procedure

Other outcomes

1

Endoscopy metrics - cecal intubation rate

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

Time frame
During procedure
2

Endoscopy metrics - cecal intubation time

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

Time frame
During procedure

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Humanitas Clinical and Research Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: