Remimazolam Versus Propofol for Procedural Sedation in Gastrointestinal Endoscopy: A Single-Centre Prospective Observational Comparative Study in a High-Risk Population

StatusCompleted
PhaseNot specified
Started

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Record History

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  1. Phase changed: Phase 4 → not specified Show 8 more changesShow less
    • Primary endpoints: details revised at 1 of 3 entries
    • Trial completed
    • Study completion date changed from estimate of May 1, 2026 to Jun 1, 2026
    • Enrollment target: estimated 200 to confirmed 203
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 6 of 13 entries
    • Collaborators: details revised at 1 of 1 entry
    • Study title expanded, about 14 words
  2. Trial status: Recruiting to Active, Not Recruiting
    • Primary and study completion dates: Mar 1, 2026 to May 1, 2026
    • Site details revised
    v2
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Remimazolam is a new, ultra-short-acting benzodiazepine approved in Romania for procedural sedation. It shows significant clinical benefits compared to other sedatives like Propofol or Midazolam, especially in elderly or high-risk patients. Advantages include better hemodynamic stability, reduced respiratory depression, lower incidence of postoperative delirium, and rapid recovery without residual sedation. It is metabolized by liver esterases and is less affected by organ dysfunction. Clinical studies suggest that remimazolam may be a safer and more effective alternative in procedural and general anesthesia. The findings support the development of institutional protocols for its use, particularly in high-risk populations and endoscopic procedures.
Trial Details
NCT Number NCT07362173
Lead Sponsor Iuliu Hatieganu University of Medicine and Pharmacy
Collaborators: Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
Conditions
(from sponsor)		 ASA Class III/IV Patients, COPD III/IV, Age 65 and Older, Multiple Organ Failure
Related terms Multiple Organ Failure
Enrollment 203 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov