Remimazolam for Colonoscopy in IBD Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intravenous remimazolam (5 mg initially, with optional 2.5 mg boluses) plus fentanyl (100 mcg) for procedural sedation., Intravenous midazolam (3 mg initially, with optional 3 mg boluses) plus fentanyl (100 mcg) for procedural sedation..
- Who it may be relevant to
- Registry conditions: IBD (Inflammatory Bowel Disease). Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Interventions
- Drug Intravenous remimazolam (5 mg initially, with optional 2.5 mg boluses) plus fentanyl (100 mcg) for procedural sedation.
\- 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. - Drug Intravenous midazolam (3 mg initially, with optional 3 mg boluses) plus fentanyl (100 mcg) for procedural sedation.
\- 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 outcome measures
- Patient satisfaction [Time frame: Immediately post-procedure]
Secondary outcome measures (5)
- Patient high satisfaction [Time frame: Immediately post-procedure]
- Incidence of treatment-emergent adverse events [Time frame: Throughout the observation period (i.e., until discharge)]
- Discharge readiness 10' [Time frame: 10 minutes post-procedure]
- Dischatge readiness 20' [Time frame: 20 minutes post-procedure]
- Maximum net benefit [Time frame: 10 minutes post-procedure]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Humanitas Research Hospital — Rozzano
Identifiers
NCT: NCT07161297 · IBD-REMI 2223386_1