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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-64
SponsorBeijing Shijitan Hospital, Capital Medical University

About this trial

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 criteria

Qualifiers

Aged between 18 and 64 years

Scheduled to undergo elective non-cardiac surgery

Planned for general anesthesia

With or without combined regional nerve blockade

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Remimazolam Besylate
  • Dexmedetomidine Hydrochloride

Treatment groups

306 Participants
are divided into 2 treatment groups