A Study of Remimazolam Tosilate for Prolonged Sedation in the ICU (NCT05913336) | Clinical Trial Compass
CompletedPhase 1/2
A Study of Remimazolam Tosilate for Prolonged Sedation in the ICU
China24 participantsStarted 2023-06-27
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for prolonged sedation(≥72h) during mechanical ventilation in the ICU.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients or their guardians are able to provide a written informed consent
. 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
. Age ≥ 18 and ≤ 80 years, male or female
. Body mass index (BMI) \> 18 and \< 30 kg/m2
Exclusion criteria
. participants (other than in endotracheal intubation) who are expected to require neuro-muscle blockers during sedation；
. Suffering from mental disorders (such as schizophrenia, depression, etc.) and cognitive dysfunction;
. Organ failure during screening period；
. Subjects who were receiving dialysis during the screening period or who were expected to require dialysis treatment during the study period;
. History of epilepsy or status epilepticus;
. Subjects with a history of drug abuse；
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of sedation success, sedation success is defined as the percentage of time maintaining target sedation in the entire drug administering time ≥ 70% without rescue sedation.
Timeframe: within 72 hours after administration of research drug