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New sedative could be safer for frail patients during medical procedures

NCT ID NCT07362173

Symptom relief Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares remimazolam, a new ultra-short-acting sedative, to propofol in 200 patients aged 65 or older with serious health conditions. The goal is to see if remimazolam provides better heart and breathing stability during endoscopic procedures. Researchers will also measure patient and doctor satisfaction and recovery quality.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
remimazolam
What this could lead to
If successful, remimazolam could become a safer sedation option for elderly or frail patients, reducing complications like low blood pressure or breathing problems.
What could go wrong
This is a phase 4 study with 200 participants, so results may not apply to all patients. Remimazolam is already approved, but the trial focuses on specific high-risk groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease multiple organ dysfunction syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Age 65 and older Asa class III/IV patients COPD iii/IV Multiple organ failure

Contacts and locations

Locations

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

    Cluj-Napoca, Cluj, Romania

More trials for these conditions

Other studies related to the condition(s) this trial covers.