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Completed NCT07362173

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

Conditions: ASA Class III/IV Patients, COPD III/IV, Age 65 and Older, Multiple Organ Failure

Sex: All
Ages: 65 Years – N/A
Healthy volunteers: No
Enrollment: 203
Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy

Location: Regional Institute of Gastroenterology-Hepatology Prof. Dr. Octavian Fodor Cluj-Napoca Cluj

Summary

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.

Eligibility Criteria

Inclusion Criteria: * Adults aged 65 years or older * ASA Physical Status classification III or IV * Patients scheduled to undergo endoscopic procedures requiring procedural sedation * Ability to provide written informed consent Exclusion Criteria: * Age below 65 years * Pediatric population * Refusal or inability to provide informed consent * Severe allergy to study drugs * Pregnancy or breastfeeding

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07362173). StuddyBuddy aggregates publicly available trial information.