Comparing Remimazolam Besylate and Propofol for Sedation in Adults After Cardiac Surgery in Intensive Care

What this Trial Is About

Researchers are evaluating sedation methods for patients recovering in intensive care after cardiac surgery who require mechanical ventilation. The study compares two sedative drugs, remimazolam besylate and propofol, to determine which provides effective sedation with fewer side effects and quicker awakening to support earlier breathing tube removal. This trial is a prospective, single-center, randomized study focusing on sedation quality and safety in adults aged 18 and older. Participants are randomly assigned to receive either remimazolam or propofol through intravenous infusion. The remimazolam group starts at 0.2 mgkgh, adjustable up to 2 mgkgh, while the propofol group starts at 1 mgkgh, adjustable up to 4 mgkgh. Both aim to maintain a sedation level measured by the Richmond Agitation-Sedation Scale RASS between -2 and 0. If the maximum dose is insufficient, dexmedetomidine is added as a rescue sedative. Sedation is targeted until extubation, expected within 48 hours. During the study, participants will be monitored up to 28 days for sedation effectiveness, extubation success, vital signs, ventilator-free days, cognitive function assessed by the Confusion Assessment Method for the ICU CAM-ICU, length of ICU stay, and mortality. The primary outcome is the percentage of time spent within the target sedation range over two days. Safety and recovery assessments help determine if remimazolam is a suitable sedative option for this patient group.

Remimazolam Besylate in Sedation of Postcardioperative Patients