Effect of Preoperative Sleep Intervention on Postoperative Delirium in Adult Patients Undergoing Cardiac Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYan Fuxia

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

1,281 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Yan Fuxia

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Sponsor institution