New sedative shows promise for Long-Term ICU sedation
NCT ID NCT05913336
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-phase trial tested a sedative called remimazolam tosilate in 24 ICU patients who needed to be on a breathing machine for at least three days. The goal was to see if the drug could keep patients at the right sedation level safely. Because this is a small, non-randomized study, the results are preliminary and more research is needed.
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 provide a safer or more controllable sedation option for ICU patients who need to be on a breathing machine for days.
- What could go wrong
- This is a very early, small study (24 people) with no comparison group, so results may not apply broadly. The drug may not work as well as current sedatives or could have unexpected side effects.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
24 people
The number who actually took part.
- Started
-
Jun 2023
- Finished
-
Mar 2025
- Lead sponsor
-
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
-
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.
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 or their guardians are able to provide a written informed consent 2. Subjects have been treated with endotracheal intubation and mechanical ventilation, and is expected to receive sedation after randomization. The target level and duration of sedation meet the criteria 3. Age ≥ 18 and ≤ 80 years, male or female 4. Body mass index (BMI) \> 18 and \< 30 kg/m2 Exclusion Criteria: 1. participants (other than in endotracheal intubation) who are expected to require neuro-muscle blockers during sedation； 2. Suffering from mental disorders (such as schizophrenia, depression, etc.) and cognitive dysfunction; 3. Organ failure during screening period； 4. Subjects who were receiving dialysis during the screening period or who were expected to require dialysis treatment during the study period; 5. History of epilepsy or status epilepticus; 6. Subjects with a history of drug abuse； 7. Myasthenia gravis or a history of myasthenia gravis; 8. severe arrhythmias or heart disease; 9. Subjects after neurosurgery operation； 10. participants who did not require continuous sedation during mechanical ventilation for endotracheal intubation; 11. Abnormal values of the laboratory examination 12. Subjects who required vasopressor medication to maintain normotensive blood pressure during the screening period (excluding subjects who used vasopressor medication only during surgery); 13. Allergic to relevant drugs ingredient or component; 14. Pregnant or nursing women; 15. Subjects who has participated in clinical trials of other interventions recently; 16. Other conditions deemed unsuitable to be included.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Sedation in the icu are added.
Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550001, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.