New sedative aims to calm ICU patients safely
NCT ID NCT06222294
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 3 trial tested a sedative called remimazolam tosilate in 214 ICU patients who were on breathing machines. The goal was to see if it works as well as or better than the standard sedative propofol. Patients received either remimazolam or propofol, and researchers measured how often they stayed at the right sedation level without needing extra medication.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- remimazolam tosilate
- What this could lead to
- If successful, this could offer a safer sedation option for ICU patients on breathing machines.
- What could go wrong
- This is a completed Phase 3 trial, but results are not yet published. Remimazolam may not be more effective or safer than current sedatives like propofol.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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214 people
The number who actually took part.
- Started
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Mar 2024
- Finished
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Sep 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1. Patients and/or their guardians are able to provide a written informed consent, understand and agree to comply with the study requirements and protocol. 2. Subjects have been treated with endotracheal intubation and mechanical ventilation, and are expected to receive sedation after randomization at least 6 hours. The target sedation level during the period is -2 ≤ RASS ≤ +1. 3. 18 years to 80 years old, male or female. 4. 18 kg/m2 ≤ BMI ≤ 30 kg/m2. Exclusion Criteria: 1. Deep sedation is required, or continuous sedation is not needed during the study process. 2. Participants (other than in endotracheal intubation) who are expected to require neuro-muscle blockers during sedation. 3. History of epilepsy or status epilepticus. 4. Myasthenia gravis or a history of myasthenia gravis. 5. Severe arrhythmias or heart disease; the circulatory system is unstable. 6. Subjects with a history of severe cardiovascular disease, or cerebrovascular disease, or neurological disease, or mental illness. 7. Subjects with a history of drug abuse. 8. Organ failure before randomization. 9. Abnormal values of the laboratory examination. 10. Allergic to relevant drugs ingredient or component. 11. Pregnant or nursing women. 12. Subjects who has participated in clinical trials of other interventions recently. 13. Other conditions deemed unsuitable to be included.
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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
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The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
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