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

Plain Language Summary

Simplified for easier understanding

This study is looking at whether a sedation medication called remimazolam works safely and effectively for older patients having endoscopic procedures (like colonoscopies or upper GI scopes) who need sedation to stay comfortable. **You may be eligible if...** - You are 65 years old or older - You have been classified as having moderate-to-severe health conditions (ASA Class III or IV) - You are scheduled for an endoscopy that requires sedation - You can provide written consent to participate **You may NOT be eligible if...** - You are younger than 65 - You have a severe allergy to the study medications - You are pregnant or breastfeeding - You are unable or unwilling to give consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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