New sedative could help ventilator patients breathe easier

NCT ID NCT07596589

Disease control Sponsor: Southeast University, China Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether remimazolam, a newer sedative, can improve outcomes for ICU patients who need a breathing tube and sedation. Researchers will compare remimazolam to standard sedatives in 80 adults. The main goal is to see if patients spend more days free from the ventilator, with fewer side effects like confusion.

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 ICU patients on ventilators, potentially reducing time on the ventilator and complications like delirium.
What could go wrong: This is a small, single-center pilot study with only 80 participants, so results may not apply broadly. The drug may not prove better than current sedatives, and side effects are still being evaluated.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 80 people

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

Started

Apr 2025

Expected to finish

Jan 2027

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

18 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: * Age ≥ 18 years; * Endotracheal intubation and mechanical ventilation for 24-96 hours before enrollment Expected need for continued invasive ventilation and sedation for at least 24 hours; * Target sedation depth on the Richmond Agitation-Sedation Scale (RASS) between 0 and -3; * Informed consent obtained from the patient's family Exclusion Criteria: * Body mass index (BMI) \> 30 kg/m² * Severe central nervous system disease (e.g., acute stroke, uncontrolled seizures, or severe dementia) or any other condition that precludes RASS assessment * Mean arterial pressure (MAP) \< 55 mmHg despite intravenous fluid resuscitation and vasopressors * Heart rate \< 50 beats per minute, or second-degree or third-degree atrioventricular block in the absence of a pacemaker * Acute myocardial infarction or severe heart failure (New York Heart Association \[NYHA\] class IV) * Left ventricular ejection fraction \< 30% * Any contraindication or allergy to benzodiazepines * Substance dependence, alcohol abuse, or psychiatric/psychological disorders. Alcohol abuse was defined as regular consumption of \> 14 drinks per week (1 drink = 150 mL wine, 360 mL beer, or 45 mL liquor) * Acute hepatitis or severe hepatic dysfunction (Child-Pugh class C) * Chronic kidney disease with a glomerular filtration rate (GFR) \< 60 mL/min/1.73 m² * Neuromuscular disease * Patients on extracorporeal membrane oxygenation (ECMO) * Pregnancy or breastfeeding

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As listed by the trial registrant

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

Mechanically ventilated icu patients Remimazolam besylate Sedation

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

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A doctor treating you

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New sedative could help ventilator patients breathe easier

What the study statuses mean