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

Yan Fuxia

Status: Not yet enrolling

Conditions: Delirium - Postoperative; CABG; Sleep Problems; Valve Surgery

Treatments: Other: Placebo intervention; Behavioral: Cognitive behavioral therapy intervention; Dietary Supplement: Melatonin intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06777342

2024-2417

Details and patient eligibility

About

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.

Enrollment: 1,281 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,281 participants in 3 patient groups, including a placebo group

Placebo group

Placebo Comparator group

Treatment:

Other: Placebo intervention

Placebo and cognitive behavioral therapy intervention group

Experimental group

Treatment:

Other: Placebo intervention

Behavioral: Cognitive behavioral therapy intervention

Melatonin and cognitive behavioral therapy intervention group

Experimental group

Treatment:

Dietary Supplement: Melatonin intervention

Behavioral: Cognitive behavioral therapy intervention