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

NCT06777342 | Not Yet Recruiting

• 1 other identifier: 2024-2417
• Study Type: interventional
• Target: 1,281
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Delirium - Postoperative; Sleep Problems; CABG; Valve Surgery

Outcome Measures

Primary Outcomes (1)

• The incidence of postoperative delirium

  Postoperative 7 days or before discharge

Secondary Outcomes (4)

• Postoperative sleep quality

  Postoperative 7 days or before discharge

• Postoperative cognitive function

  The 7th day after surgery or before discharge

• Duration and severity of delirium

  Postoperative 7 days or before discharge

• Postoperative mood and anxiety

  The 7th day after surgery or before discharge

Other Outcomes (15)

• Postoperative pain score

  Postoperative 7 days or before discharge

• Types and doses of postoperative sedative and analgesic drugs

  Postoperative 7 days or before discharge

• Postoperative nausea and vomiting

  Postoperative 7 days or before discharge

Study Arms (3)

Placebo group

PLACEBO COMPARATOR

Other: Placebo intervention

Placebo and cognitive behavioral therapy intervention group

EXPERIMENTAL

Behavioral: Cognitive behavioral therapy intervention; Other: Placebo intervention

Melatonin and cognitive behavioral therapy intervention group

EXPERIMENTAL

Behavioral: Cognitive behavioral therapy intervention; Dietary Supplement: Melatonin intervention

Interventions

Cognitive behavioral therapy intervention BEHAVIORAL

The cognitive behavioral intervention provides sleep-related education 7-14 days before surgery. The educational content should include the following aspects: 1) Establish a consistent bedtime and wake-up time, recommending a sleep schedule from 22:00 to 07:00, and avoid prolonged daytime naps; 2) Optimize the sleep environment by ensuring a quiet setting, turning off lights, and refraining from using mobile phones, computers, and other electronic devices 30 minutes before bedtime; 3) Manage diet by avoiding caffeinated foods such as chocolate, tea, and cola; 4) Engage in appropriate daytime activities as permitted by the patient's condition.

Melatonin and cognitive behavioral therapy intervention group; Placebo and cognitive behavioral therapy intervention group

Melatonin intervention DIETARY_SUPPLEMENT

Patients in the melatonin intervention group are required to take an oral melatonin of 5 mg at 30-60 minutes before sleep (administered at 21:00) nightly for 7 to 14 days before surgery. The melatonin was provided by Kangenbei Pharmaceutical Co., LTD. (Hangzhou, Zhejiang, China).

Melatonin and cognitive behavioral therapy intervention group

Placebo intervention OTHER

Patients in the placebo group need to take oral placebos of 5 mg at 30-60 minutes (administered at 21:00) before sleep, nightly, for 7 to 14 days before surgery. The placebo is provided by Guangzhou Boji Biomedical Science Park Co., LTD. (Guangzhou, Guangdong, China).

Placebo and cognitive behavioral therapy intervention group; Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Severe hepatic dysfunction (Child-Pugh Grade C) or renal dysfunction (chronic kidney disease stages 3-4).
• Contraindications to melatonin use, such as allergies to melatonin-related ingredients.
• Currently taking melatonin, melatonin receptor agonists, sleep-related medications, sedatives, antipsychotic medications, or opioids.
• Inability to communicate due to hearing or speech impairment, or refusal to provide informed consent.

Sponsors & Collaborators

• Yan Fuxia: lead

MeSH Terms

Conditions

Emergence Delirium; Parasomnias

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Sleep Wake Disorders

Central Study Contacts

Fuxia Yan

CONTACT

010 88396628; yanfuxia@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 15, 2025
• Study Start: February 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 15, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share