Remimazolam for Colonoscopy in IBD Patients

Обзор

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

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Patient satisfaction [Срок оценки: Immediately post-procedure]

Вторичные конечные точки (5)

• Patient high satisfaction [Срок оценки: Immediately post-procedure]
• Incidence of treatment-emergent adverse events [Срок оценки: Throughout the observation period (i.e., until discharge)]
• Discharge readiness 10' [Срок оценки: 10 minutes post-procedure]
• Dischatge readiness 20' [Срок оценки: 20 minutes post-procedure]
• Maximum net benefit [Срок оценки: 10 minutes post-procedure]

Критерии участия

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Humanitas Research Hospital — Rozzano

Идентификаторы

NCT: NCT07161297 · IBD-REMI 2223386_1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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