Actualities in Procedural Sedation: Remimazolam

NCT07362173 | Active Not Recruiting Phase 4

• 1 other identifier: 5129/29.04.2025, AVZ213/21.07
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Heart rate (beats per minute)

  The lowest heart rate will be recorded

  Periprocedural

• Mean arterial pressure (mmHg)

  The lowest mean arterial pressure will be recorded

  Periprocedural

• Incidence of hypotension requiring vasoactive support (Yes/No)

  The presence of hypotension requiring vasoactive drug administration will be recorded.

  Periprocedural

Secondary Outcomes (13)

• Patient satisfaction

  Postprocedural

• Endoscopist satisfaction (5-point Likert scale)

  Periprocedural

• Quality of recovery (ordinal scale)

  Periprocedural

• Incidence of postoperative nausea and vomiting (Yes/No)

  Periprocedural

• Total dose of sedative administered (mg)

  Periprocedural

Study Arms (2)

Remimazolam

ACTIVE COMPARATOR

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.

Drug: Administering remimazolam

Propofol

ACTIVE COMPARATOR

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.

Drug: Administering propofol

Interventions

Administering remimazolam DRUG

Administering Remimazolam for procedural sedation

Remimazolam

Administering propofol DRUG

Administering Propofol for procedural sedation

Propofol

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Iuliu Hatieganu University of Medicine and Pharmacy: lead
• Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor: collaborator

Study Sites (1)

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

Cluj-Napoca, Cluj, Romania

Location

MeSH Terms

Conditions

Multiple Organ Failure

Condition Hierarchy (Ancestors)

Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: January 23, 2026
• Study Start: March 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 25, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)