RecruitingPhase 4NCT07362173

Actualities in Procedural Sedation: Remimazolam


Sponsor

Iuliu Hatieganu University of Medicine and Pharmacy

Enrollment

200 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 65 Years

Inclusion Criteria4

  • 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 Criteria5

  • Age below 65 years
  • Pediatric population
  • Refusal or inability to provide informed consent
  • Severe allergy to study drugs
  • Pregnancy or breastfeeding

Interventions

DRUGAdministering remimazolam

Administering Remimazolam for procedural sedation

DRUGAdministering propofol

Administering Propofol for procedural sedation


Locations(1)

Regional Institute of Gastroenterology-Hepatology Prof. Dr. Octavian Fodor

Cluj-Napoca, Cluj, Romania

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NCT07362173


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