Actualities in Procedural Sedation: Remimazolam

March 23, 2026 updated by: Iuliu Hatieganu University of Medicine and Pharmacy
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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Heart rate (beats per minute)
Time Frame: Periprocedural
The lowest heart rate will be recorded
Periprocedural
Mean arterial pressure (mmHg)
Time Frame: Periprocedural
The lowest mean arterial pressure will be recorded
Periprocedural
Incidence of hypotension requiring vasoactive support (Yes/No)
Time Frame: Periprocedural
The presence of hypotension requiring vasoactive drug administration will be recorded.
Periprocedural

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: Postprocedural
Patient satisfaction will be recorded as a single score per participant.
Postprocedural
Endoscopist satisfaction (5-point Likert scale)
Time Frame: Periprocedural
Endoscopist satisfaction will be evaluated and recorded as a single 5-point Likert score per participant.
Periprocedural
Quality of recovery (ordinal scale)
Time Frame: Periprocedural
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)
Time Frame: Periprocedural
The presence of nausea and/or vomiting will be recorded.
Periprocedural
Total dose of sedative administered (mg)
Time Frame: Periprocedural
Total intravenous dose of the sedative agent administered during the procedure.
Periprocedural
Need for airway intervention due to apnea (Yes/No)
Time Frame: Periprocedural
The need for airway support due to apnea will be recorded.
Periprocedural
Incidence of apnea (Yes/No)
Time Frame: Periprocedural
The occurrence of apnea during procedural sedation will be recorded.
Periprocedural
Peripheral oxygen saturation (SpO₂,%)
Time Frame: Periprocedural
Peripheral capillary oxygen saturation will be measured using pulse oximetry and summarized as the mean periprocedural value.
Periprocedural
Respiratory rate (breaths per minute)
Time Frame: Periprocedural
Respiratory rate will be monitored during the periprocedural period.
Periprocedural
Duration of apnea (seconds)
Time Frame: Periprocedural
Duration of apnea episodes will be measured in seconds.
Periprocedural
Need for change in sedation regimen (Yes/No)
Time Frame: Periprocedural
The need to change the planned sedation regimen will be recorded.
Periprocedural
Incidence of postprocedural delirium (Yes/No)
Time Frame: Periprocedural
Postprocedural delirium or agitation will be recorded.
Periprocedural
Incidence of adverse events (Yes/No)
Time Frame: Periprocedural
The occurrence of adverse events related to procedural sedation will be recorded.
Periprocedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Iuliu Hatieganu University of Medicine and Pharmacy

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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