Clinical trial NCT06777342: Effect of Preoperative Sleep Intervention on Postoperative Delirium in Adult Patients Undergoing Cardiac Surgery
Official title: Effect of Preoperative Sleep Intervention on Postoperative Delirium in Adult Patients Undergoing Cardiac Surgery: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Delirium - Postoperative
Sleep Problems
CABG
Valve Surgery
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 1281
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria:

1. Age ≥ 18 years.
2. Scheduled for elective coronary artery bypass grafting and/or valve surgery.
3. Preoperative Pittsburgh Sleep Quality Index (PSQI) score ≥ 5.

Exclusion Criteria:

1. History of neurosurgery, cerebral hemorrhage, cerebral infarction, delirium, dementia, or other neurological diseases.
2. History of mental illness.
3. Habitual heavy drinking.
4. American Society of Anesthesiologists (ASA) grade IV or above.
5. Severe hepatic dysfunction (Child-Pugh Grade C) or renal dysfunction (chronic kidney disease stages 3-4).
6. Contraindications to melatonin use, such as allergies to melatonin-related ingredients.
7. Currently taking melatonin, melatonin receptor agonists, sleep-related medications, sedatives, antipsychotic medications, or opioids.
8. Inability to communicate due to hearing or speech impairment, or refusal to provide informed consent.

Primary outcomes:
measure: The incidence of postoperative delirium
timeFrame: Postoperative 7 days or before discharge
Secondary outcomes:
measure: Postoperative sleep quality
timeFrame: Postoperative 7 days or before discharge
measure: Postoperative cognitive function
timeFrame: The 7th day after surgery or before discharge
measure: Duration and severity of delirium
timeFrame: Postoperative 7 days or before discharge
measure: Postoperative mood and anxiety
timeFrame: The 7th day after surgery or before discharge
Other outcomes:
measure: Postoperative pain score
timeFrame: Postoperative 7 days or before discharge
measure: Types and doses of postoperative sedative and analgesic drugs
timeFrame: Postoperative 7 days or before discharge
measure: Postoperative nausea and vomiting
timeFrame: Postoperative 7 days or before discharge
measure: Postoperative markers of oxidative stress and inflammation
timeFrame: 24 hours after surgery
measure: Postoperative mechanical ventilation time and Intensive Care Unit stay time
timeFrame: Postoperative 7 days or before discharge
measure: Length of hospital stay
timeFrame: 30 days after surgery
measure: In-hospital mortality
timeFrame: Postoperative 7 days or before discharge
measure: Serious adverse cardiovascular events
timeFrame: Postoperative 7 days or before discharge
measure: Long-term survival
timeFrame: 30 days after surgery
measure: Long-term survival
timeFrame: 12 months after surgery
measure: Long-term sleep quality
timeFrame: 30 days after surgery
measure: Long-term sleep quality
timeFrame: 12 months after surgery
measure: Long-term pain
timeFrame: 30 days after surgery
measure: Long-term pain
timeFrame: 12 months after surgery
measure: Total hospitalization costs
timeFrame: 30 days after surgery
Locations:
Study officials:
References: