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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

RecruitingNAAges 65 Years - 90 YearsAllNanjing First Hospital, Nanjing Medical University
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In plain words

What the trial is, and whether it could suit you

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 Rich

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria 1\. Age โ‰ฅ65 years. 2. Undergoing elective cardiac surgery with cardiopulmonary bypass, including coronary artery bypass grafting (CABG), valve surgery, or combined CABG and valve surgery. 3\. Admission to the cardiac surgery intensive care unit (ICU) after surgery, with an anticipated need for invasive mechanical ventilation and continuous sedation for at least 2 hours. 4\. Written informed consent obtained from the participant or their legally authorized representative. 5\. No delirium identified during the preoperative assessment. Exclusion Criteria 1. Emergency or salvage cardiac surgery. 2. Heart transplantation, ventricular assist device implantation, surgery for aortic dissection requiring deep hypothermic circulatory arrest, or other cardiac procedures outside the scope of this study. 3. Severe psychiatric disorders, diagnosed Alzheimer's disease or dementia, or preoperative delirium. 4. Severe alcohol use disorder or a history of severe alcohol misuse. 5. Previous cerebrovascular events or other conditions causing severe visual, hearing, or communication impairment that would prevent reliable delirium assessment despite appropriate assistance. 6. Known hypersensitivity or contraindications to either study drug or its excipients, or severe hepatic or renal failure. 7. Decompensated acute circulatory failure or hemodynamic instability at the time of randomization. 8. Concurrent participation in another interventional clinical trial that could affect the primary outcome.
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What it tests

  • Remimazolam Tosylate
  • Propofol
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Where

1 site
Nanjing First Hospital
Nanjing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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