Remimazolam vs. Propofol for Sedation After Cardiac Surgery in Older Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, prospective, randomized, double-blind, double-dummy, active-controlled superiority trial enrolling 600 patients aged 65 or older undergoing elective cardiac surgery with cardiopulmonary bypass. Participants are randomized 1:1 to receive either remimazolam tosylate or propofol for continuous ICU sedation, with dose adjustments to maintain a target RASS of -2 to 0 and standardized analgesia. The primary aim is to determine if remimazolam tosylate reduces the incidence of postoperative delirium compared with propofol. The study excludes emergency surgeries, certain complex cardiac procedures, severe psychiatric conditions, dementia, and recent substantial alcohol misuse. Outcomes include delirium incidence and safety under standardized postoperative care in the ICU.

Why it matters

Who can join: the full rules

Inclusion Criteria

1\. Age ≥65 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.

Where it's running

• Nanjing First Hospital
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: liang hong, doctor
• Email: hlblade@gmail.com
• Phone: +86 13914755401

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Personalized iPad audio messages to reduce confusion after hip fracture surgery

  This trial will try 2-minute personalized audio reorientation messages on an iPad to see if they help prevent confusion (delirium) in people aged 60 and over after hip fracture surgery.

  Recruiting Sengkang General Hospital · Singapore · NCT07396532

• Impact of Fast-Track Anesthesia on Postoperative Delirium After Cardiac Surgery

  This observational study tests whether fast-track anesthesia, compared with conventional care, is linked to lower rates of delirium after elective cardiac surgery in adults.

  Recruiting Second Affiliated Hospital of Nanchang University · Nanchang, Jiangxi · NCT07923344

• Dexmedetomidine to See if Delirium Drops After Hip Fracture Surgery

  This observational study tests whether using dexmedetomidine around hip fracture surgery helps prevent postoperative delirium in adults 65 and older.

  Recruiting Aarhus University Hospital · Aarhus · NCT07867899

• How different pain control methods affect early mobilization after major surgery in older ICU patients

  In this real-world study, researchers will observe how pain-relief methods used after major surgery in adults 65 and older in the ICU relate to how quickly they get out of bed and start moving.

  Recruiting Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization · Istanbul, Istanbul · NCT07709975

• VR-based cognitive games to help prevent delirium after big surgery

  A VR-based cognitive stimulation game is being tested to see if it can help prevent delirium in adults 65 and older after major surgery.

  Recruiting at 2 sites The Methodist Hospital Research Institute · Houston, Texas and 1 other locations · NCT07641153

• Sleep problems before heart surgery may affect recovery outcomes

  This study tests whether preoperative sleep issues in adults undergoing cardiac surgery are linked to different perioperative metabolites and postoperative outcomes.

  Recruiting Chinese Academy of Medical Sciences, Fuwai Hospital · Beijing, Beijing Municipality · NCT07588178

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.