Assessing the safety and effectiveness of remazolam besylate for sedation in critically ill patients on ventilators after surgery
Official title: Efficacy and Safety of Remimazolam Besylate for Sedation in Post-Non-Cardiac Surgery Patients Requiring Mechanical Ventilation: A Randomized Controlled Trial
Run by Beijing Shijitan Hospital, Capital Medical University · NCT06575530 · Data updated 2026-11-12
This study is testing if a new sedative called remazolam besylate is safe and effective for helping critically ill patients on ventilators after surgery, compared to a standard sedative.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Enrollment | 306 (estimated) |
| Sponsor | Beijing Shijitan Hospital, Capital Medical University Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | January 20, 2025 |
| Main results expected | May 30, 2026 |
| Study ends | June 30, 2026 |
| Registry record updated | June 16, 2026 |
| Trial ID | NCT06575530 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18-64 who are undergoing non-cardiac elective surgery and require mechanical ventilation post-operatively.
✕Probably not a fit
Patients with severe neurological conditions, significant cardiac dysfunction, or those who are pregnant or lactating may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial is a multi-center, prospective, randomized, double-blind, no-inferiority study aimed at evaluating the safety and efficacy of remazolam besylate compared to dexmedetomidine for sedation in critically ill patients who are mechanically ventilated following elective surgery. Participants will be adults aged 18-64 who require light to moderate sedation and have been admitted to the ICU with tracheal intubation. The study will focus on measuring the effectiveness of sedation and monitoring for any adverse drug events during the mechanical ventilation period.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective sedation option for critically ill patients requiring mechanical ventilation after surgery.
How similar studies have gone: While there have been studies on sedation in critically ill patients, the specific use of remazolam besylate in this context is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Beijing Shijitan Hospital.CMU
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Yuefu Wang, doctor
- Email: wangyuefu3806@bjsjth.cn
- Phone: +86
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.