Remimazolam Besylate Versus Propofol for Short-Term Sedation in Critically Ill Patients Receiving Mechanical Ventilation: Protocol for a Multicenter Randomized Non-inferior Trial.

INTRODUCTION

Remimazolam besylate is a novel ultra-short-acting benzodiazepine that is increasingly used in intensive care unit (ICU) sedation. The aim of this study is to assess whether remimazolam besylate is non-inferior to propofol for short-term sedation during invasive mechanical ventilation in critically ill patients.

METHODS

This is a multicenter, randomized, single-blind, non-inferiority study. Eligible patients will be randomized to receive remimazolam besylate or propofol intravenously in a 1:1 ratio. The target sedation level is a Richmond Agitation-Sedation Scale score of - 2 to + 1. Patients in the remimazolam group receive a maintenance infusion of remimazolam besylate of 0.2 mg/kg/h, titrated up to a maximum of 2.0 mg/kg/h or down by 0.1 mg/kg/h to achieve the target sedation level. Patients in the propofol group receive a maintenance infusion of propofol of 0.3 mg/kg/h, titrated up to a maximum of 4.0 mg/kg/h or down by 0.3 mg/kg/h to achieve the target sedation level.

PLANNED OUTCOMES

The primary outcome is the proportion of subjects with successful sedation during the administration of the study drug. The secondary outcomes include the percentage of time within the target sedation level of the total duration of the study drug infusion, the proportion of subjects reaching the target sedation level, the number of additional administration of the study drug, the proportion of subjects receiving additional administration of the study drug, total dosage of remifentanil, the proportion of subjects using rescue sedatives, recovery time, weaning time, successful extubation, and ICU discharge time. Adverse events occurring during the study are also recorded.

TRIAL REGISTRATION

ClinicalTrials.gov identifier, NCT05782894.