Actualities in Procedural Sedation: Remimazolam

Iuliu Hatieganu University of Medicine and Pharmacy

Status and phase: Enrolling; Phase 4

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

Treatments: Drug: Administering propofol; Drug: Administering remimazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT07362173

5129/29.04.2025, AVZ213/21.07

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Remimazolam

Active Comparator group

Description:

Lot 1 - Participants in this arm will receive remimazolam for procedural sedation. Remimazolam will be administered intravenously according to the institutional sedation protocol, with dosing adjusted to achieve adequate procedural sedation.

Treatment:

Drug: Administering remimazolam

Propofol

Active Comparator group

Description:

Lot 2 - Participants in this arm will receive Propofol for procedural sedation. Propofol will be administered intravenously according to standard clinical practice, with dosing adjusted to achieve adequate procedural sedation.

Treatment:

Drug: Administering propofol