Efficacy and Safety of Remimazolam Besylate for Sedation in Post-Non-Cardiac Surgery Patients Req… (NCT06575530) | Clinical Trial Compass
RecruitingPhase 4
Efficacy and Safety of Remimazolam Besylate for Sedation in Post-Non-Cardiac Surgery Patients Requiring Mechanical Ventilation
China306 participantsStarted 2025-01-20
Plain-language summary
A multi-center, prospective, randomized, double-blind, active-controlled, no-inferiority clinical trial conducted across 5 tertiary medical centers in China. The objective of this RCT is to evaluate the sedative efficacy and safety profile of remimazolam besylate compared with dexmedetomidine in patients requiring mechanical ventilation following non-cardiac surgery. The study hypothesized that remimazolam besylate is non-inferior to dexmedetomidine regarding the primary efficacy outcome.
Who can participate
Age range
18 Years – 64 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:
* Aged between 18 and 64 years
* Scheduled to undergo elective non-cardiac surgery
* Planned for general anesthesia
* With or without combined regional nerve blockade
* Admitted to the ICU with endotracheal intubation post-surgery
* With an anticipated duration of postoperative mechanical ventilation greater than 24 hours
* Clinically requiring light sedation( target RASS score 0 to -2)
Exclusion Criteria:
* Undergoing intracranial surgery, or having a history of severe neurological or spinal cord diseases
* Pre-existing history of schizophrenia, epilepsy, or Parkinson's disease
* Inability to communicate preoperatively due to coma, severe dementia, or language barriers
* Preoperative .cardiac insufficiency or severe cardiac arrhythmias
* Severe hepatic impariment( Child-Pugh class C)
* Severe renal impariment
* Preoperative( within 24 hours prior to surgery) or intraoperative administration of dexmedetomidine or remimazolam
* Pregnancy or lactation
* Participation in any clinical trial involving investigational drugs within 30 days prior to enrollment
* Any other conditions deemed by the investigators to render the patient unsuitable for study participation
* Refusal to provide written informed consent
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
Percentage of time in optimal sedation
Timeframe: Through the useage of sedative drugs in the ICU, an average of 3 days
Trial details
NCT IDNCT06575530
SponsorBeijing Shijitan Hospital, Capital Medical University