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

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.

Eligibility

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

Conditions7

Interventions2

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