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The Effect of Remimazolam Tosylate on the Incidence of Postoperative Delirium in Older Patients Undergoing Cardiac Surgery: A Prospective Randomized Controlled Trial
Sponsor: Nanjing First Hospital, Nanjing Medical University
Summary
This study aims to compare the efficacy and safety of remimazolam tosylate and propofol for postoperative sedation in patients aged 65 years or older undergoing cardiac surgery with cardiopulmonary bypass. Postoperative delirium (POD) is a common complication in older patients after cardiac surgery and may adversely affect postoperative recovery and clinical outcomes. Whether remimazolam tosylate reduces the incidence of POD compared with propofol under standardized sedation and analgesia protocols remains uncertain. This is a single-center, prospective, randomized, double-blind, double-dummy, active-controlled superiority trial. A total of 600 eligible patients will be randomized in a 1:1 ratio to receive remimazolam tosylate or propofol for continuous sedation in the cardiac surgery intensive care unit (ICU). In both groups, the infusion rate will be titrated to maintain a target Richmond Agitation-Sedation Scale (RASS) score of -2 to 0, with standardized analgesia and postoperative care. The primary outcome is the incidence of POD within 7 days after surgery. Delirium will be assessed using the Confusion Assessment Method for the ICU (CAM-ICU) in patients who are intubated or unable to communicate verbally, and the Chinese version of the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM-CN) in patients who are able to communicate. Secondary clinical outcomes include time to first delirium, delirium duration and severity, achievement of the target sedation level, pain scores, rescue sedative use, time to extubation, ICU length of stay, hospital length of stay, and safety outcomes, including hypotension, bradycardia, and vasopressor use. This study aims to determine whether remimazolam tosylate reduces the incidence of POD compared with propofol in older patients after cardiac surgery. The findings may provide clinical evidence to guide postoperative sedative selection and help improve delirium prevention and postoperative recovery in this population.
Official title: Effects of Remimazolam Tosylate Versus Propofol for Postoperative Sedation on the Incidence of Postoperative Delirium in Older Patients Undergoing Cardiac Surgery: A Prospective, Double-Blind, Randomized Controlled Trial
Key Details
Gender
All
Age Range
65 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2026-09-05
Completion Date
2027-12-30
Last Updated
2026-10-30
Healthy Volunteers
Yes
Conditions
Interventions
Remimazolam Tosylate
Following postoperative ICU admission and confirmation of eligibility, participants will be randomized to the remimazolam tosylate group. Remimazolam tosylate will be administered by continuous intravenous infusion at a rate of 0.2-1 mg/kg/h. The infusion rate will be titrated according to the Richmond Agitation-Sedation Scale (RASS) to maintain a target score of -2 to 0 until the patient meets the criteria for ventilator weaning.
Propofol
Propofol will be administered by continuous intravenous infusion at a rate of 1-4 mg/kg/h, with the same target Richmond Agitation-Sedation Scale (RASS) score as the intervention group (-2 to 0).
Locations (1)
Nanjing First Hospital
Nanjing, Jiangsu, China