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
Beijing Shijitan Hospital, Capital Medical University
306 participants
Jan 20, 2025
INTERVENTIONAL
Conditions
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
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Interventions
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.
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.
Locations(1)
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NCT06575530