RecruitingPhase 4NCT06575530

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

Efficacy and Safety of Remimazolam Besylate for Sedation in Post-Non-Cardiac Surgery Patients Requiring Mechanical Ventilation: A Randomized Controlled Trial

Sponsor

Beijing Shijitan Hospital, Capital Medical University

Enrollment

306 participants

Start Date

Jan 20, 2025

Study Type

INTERVENTIONAL

Conditions

Surgery Mechanical Ventilation Complication Critical Illness Sedation Adverse Drug Event Effect of Drug

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

Min Age: 18 YearsMax Age: 64 Years

Inclusion Criteria7

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 Criteria11

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

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Interventions

DRUGRemimazolam Besylate

patients will be sedated with remimazolam via intravenous pump on the day of ICU admission, the dosage will titrate with the depth of sedation evaluated with RASS. If the target sedation depth could not to achieved within the prespecified maximum dose range of remimazolam, a standardized rescue sedation protocol will intiated as follows: an intravenous bolus of propofol at 0.2mg/kg will administered. Sedation depth will evaluated 5 minutes post-injection. The identical dose of propofol bolus will repeated until the desired sedation depth is reached. Continuous propofol infusion will initiated after three consecutive bolus injections of propofol. The continuous propofol infusion rate will titrated within the range of 0.2 to 1.0 mg/kg/h until the satisfactory target sedation depth is established. At the subsequent hourly sedation assessment, continuous propofol infusion will discontinued once the patient successfully maintained a stable RASS score within the 0 to -2 range.

DRUGDexmedetomidine Hydrochloride

patients will be sedated with dexmedetomidine hydrochloride via intravenous pump on the day of ICU admission, the dosage will titrate with the depth of sedation evaluated with RASS. If the target sedation depth could not to achieved within the prespecified maximum dose range of remimazolam, a standardized rescue sedation protocol will intiated as follows: an intravenous bolus of propofol at 0.2mg/kg will administered. Sedation depth will evaluated 5 minutes post-injection. The identical dose of propofol bolus will repeated until the desired sedation depth is reached. Continuous propofol infusion will initiated after three consecutive bolus injections. The continuous propofol infusion rate will titrated within the range of 0.2 to 1.0 mg/kg/h until the satisfactory target sedation depth is established. At the subsequent hourly sedation assessment, continuous propofol infusion will discontinued once the patient successfully maintained a stable RASS score within the 0 to -2 range.