New sedative shows promise for ventilated ICU patients
NCT ID NCT06124404
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a drug called remimazolam besylate for sedating patients in the intensive care unit who are on breathing machines. The trial involved 36 adults and compared three different doses to see how well the drug kept patients lightly sedated without needing extra medication. The goal is to find a safe and effective sedation option for this vulnerable group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- remimazolam besylate
- What this could lead to
- If successful, this could provide a safer, more controllable sedation option for ICU patients on ventilators.
- What could go wrong
- This is a small, early-phase trial with only 36 participants. The results may not apply to all ICU patients, and side effects are still being studied.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
36 people
The number who actually took part.
- Started
-
Apr 2022
- Finished
-
Feb 2023
- 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 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Body mass index (BMI) ≥18 and ≤ 30 kg/m2 * Being Intubated and mechanically ventilated ≤48 hours before enrollment and expected to be on a ventilator for at least 6 hours * Requirement for light to moderate sedation (a Richmond agitation-sedation scale score of -2 to 1) Exclusion Criteria: * Refusal to be included * Allergy or unsuitability to any composition of study drugs or remifentanil * Living expectancy less than 48 hours * Myasthenia gravis * Status asthmaticus * Abdominal compartment syndrome * Serious hepatic dysfunction (CTP 10-15); * Chronic kidney disease with glomerular filtration rate (GFR) \< 29 ml/min/1.73m2 * Mean blood pressure less than 65 mm Hg or the need for a continuous infusion of norepinephrine at ≥0.5 ug/kg/min to maintain Mean blood pressure ≥ 65 mm Hg * Possible requirement for surgery or bedside tracheostomy in 24 hours * Possible requirement for renal replacement therapy in 24 hours * Acute severe neurological disorder and any other condition interfering with sedation assessment * Abuse of controlled substances or alcohol * Pregnancy or lactation
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Wuhan Union Hospital
Wuhan, Hubei, 430022, China
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