About this trial
This is a multicenter, randomized, controlled clinical trial aimed to determine whether preoperative sleep interventions could reduce the incidence of adverse outcomes, such as postoperative delirium, in adult patients undergoing cardiac surgery. The study will include adult patients undergoing coronary artery bypass grafting and/or valve surgery with concomitant sleep disorders, as assessed by the Pittsburgh Sleep Quality Index. All participants will be randomly assigned to placebo, placebo + cognitive behavioral therapy, and melatonin + cognitive behavioral therapy in a 1:1:1 ratio. The primary outcome is the incidence of postoperative delirium within 7 days after surgery or before discharge, and secondary outcomes include postoperative cognitive function, sleep quality, and severity and duration of delirium. The results of this study will provide suggestions for the prevention of delirium after cardiac surgery.
Eligibility criteria
Qualifiers
Age ≥ 18 years.
Scheduled for elective coronary artery bypass grafting and/or valve surgery.
Preoperative Pittsburgh Sleep Quality Index (PSQI) score ≥ 5.
Disqualifiers
History of neurosurgery, cerebral hemorrhage, cerebral infarction, delirium, dementia, or other neurological diseases.
History of mental illness.
Habitual heavy drinking.
American Society of Anesthesiologists (ASA) grade IV or above.
Trial design
Treatments tested in this trial
- Cognitive behavioral therapy intervention
- Melatonin intervention
- Placebo intervention
Treatment groups
Locations
Sponsors and collaborators
Yan Fuxia
Lead sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor institution