Actualities in Procedural Sedation: Remimazolam

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Organ Failure; ASA Class III/IV Patients; Age 65 and Older; COPD III/IV
• Intervention / Treatment: Drug: Administering remimazolam; Drug: Administering propofol

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Romania
  • Cluj
    • Cluj-Napoca, Cluj, Romania
      • Regional Institute of Gastroenterology-Hepatology Prof. Dr. Octavian Fodor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Remimazolam; 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; Administering Remimazolam for procedural sedation
Active Comparator: Propofol; 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; Administering Propofol for procedural sedation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Patient satisfaction will be recorded as a single score per participant.	Postprocedural
Endoscopist satisfaction (5-point Likert scale)	Endoscopist satisfaction will be evaluated and recorded as a single 5-point Likert score per participant.	Periprocedural
Quality of recovery (ordinal scale)	Quality of recovery will be assessed using an ordinal clinical scale and reported as a single score per participant.	Periprocedural
Incidence of postoperative nausea and vomiting (Yes/No)	The presence of nausea and/or vomiting will be recorded.	Periprocedural
Total dose of sedative administered (mg)	Total intravenous dose of the sedative agent administered during the procedure.	Periprocedural
Need for airway intervention due to apnea (Yes/No)	The need for airway support due to apnea will be recorded.	Periprocedural
Incidence of apnea (Yes/No)	The occurrence of apnea during procedural sedation will be recorded.	Periprocedural
Peripheral oxygen saturation (SpO₂,%)	Peripheral capillary oxygen saturation will be measured using pulse oximetry and summarized as the mean periprocedural value.	Periprocedural
Respiratory rate (breaths per minute)	Respiratory rate will be monitored during the periprocedural period.	Periprocedural
Duration of apnea (seconds)	Duration of apnea episodes will be measured in seconds.	Periprocedural
Need for change in sedation regimen (Yes/No)	The need to change the planned sedation regimen will be recorded.	Periprocedural
Incidence of postprocedural delirium (Yes/No)	Postprocedural delirium or agitation will be recorded.	Periprocedural
Incidence of adverse events (Yes/No)	The occurrence of adverse events related to procedural sedation will be recorded.	Periprocedural

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: July 4, 2025
• First Submitted That Met QC Criteria: January 15, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Shock; Pathological Conditions, Signs and Symptoms; Multiple Organ Failure
• Other Study ID Numbers: 5129/29.04.2025, AVZ213/21.07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to the investigator-initiated nature of the study and local data protection regulations, individual participant data will not be made available for sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No