Efficacy and Safety of Remimazolam Besylate for Sedation in Post-Non-Cardiac Surgery Patients Requiring Mechanical Ventilation

Recruiting now · Phase 4

Conditions studied: Effect of Drug, Adverse Drug Event, Mechanical Ventilation Complication, Critical Illness, Surgery, Sedation

In brief

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.

Key facts

Study ID

NCT06575530

Run by

Beijing Shijitan Hospital, Capital Medical University

People needed

306

Starts

2025-01-20

Expected to finish

2026-06-30

Last updated by the study team

2026-06-16

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 is running

• Beijing Shijitan Hospital.CMU — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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