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NCT Number: NCT06777342

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

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.

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Key information

Conditions

Delirium - Postoperative CABG Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Parasomnias Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Sleep Problems Sleep Wake Disorders Valve Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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 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).

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).

Primary outcomes

  1. The incidence of postoperative delirium

    Time frame: Postoperative 7 days or before discharge

Secondary outcomes

  1. Postoperative sleep quality

    Time frame: Postoperative 7 days or before discharge

    The sleep quality was evaluated using the Actigraph model wGT3X-BT and the Sleep Quality and Nighttime Restlessness Scale (SQNRS) score. Subjects wore the Actigraph wGT3X-BT activity monitor from the beginning of their hospital admission until 7 days after surgery or before discharge. The device will record parameters such as total sleep time, wake time after falling asleep, number of awakenings, average wake time, and sleep efficiency during the first 7 days after surgery or before discharge to assess the subjects' sleep quality. Additionally, the SQNRS score was used to evaluate patients' subjective sleep quality during the same period. The SQNRS score ranges from 0 to 10, with higher scores indicating better sleep quality.

  2. Postoperative cognitive function

    Time frame: The 7th day after surgery or before discharge

    The Montreal Cognitive Assessment (MoCA) will be administered to evaluate the cognitive function of the patients 7 days after surgery or before discharge. The MoCA has a total score of 30 points, with a score above 26 indicating normal cognitive function.

  3. Duration and severity of delirium

    Time frame: Postoperative 7 days or before discharge

  4. Postoperative mood and anxiety

    Time frame: The 7th day after surgery or before discharge

    The Hospital Anxiety and Depression Scale (HADS) will be utilized to evaluate the mood and anxiety levels of the patients during the first 7 days after surgery or before discharge. The HADS scale comprises two subscales, totalling 14 items: 7 items assess anxiety, and the other 7 assess depression. Each item is scored on a scale of 0 to 3, with each subscale totalling up to 21 points. Interpretation of the scores is as follows: 0-7 indicates a normal state, 8-10 suggests mild anxiety/depression, 11-14 indicates moderate anxiety/depression, and 15-21 suggests severe anxiety/depression.

Other outcomes

  1. Postoperative pain score

    Time frame: Postoperative 7 days or before discharge

    The Visual Analogue Scale (VAS) will be employed to assess the pain levels of patients during the first 7 days after surgery or before discharge. A VAS score ranges from 0 to 10, with 1-3 indicating mild pain, 4-6 indicating moderate pain, and 7-10 indicating severe pain.

  2. Types and doses of postoperative sedative and analgesic drugs

    Time frame: Postoperative 7 days or before discharge

  3. Postoperative nausea and vomiting

    Time frame: Postoperative 7 days or before discharge

    The frequency of nausea and vomiting will be recorded daily for 7 days following surgery or before discharge, as documented during bedside consultations.

  4. Postoperative markers of oxidative stress and inflammation

    Time frame: 24 hours after surgery

    Within 24 hours after surgery, levels of malondialdehyde (MDA), ascorbic acid (AA), dehydroascorbic acid (DHA), and C-reactive protein (CRP) will be determined from 5 mL of venous blood drawn from the patients.

  5. Postoperative mechanical ventilation time and Intensive Care Unit stay time

    Time frame: Postoperative 7 days or before discharge

  6. Length of hospital stay

    Time frame: 30 days after surgery

  7. In-hospital mortality

    Time frame: Postoperative 7 days or before discharge

  8. Serious adverse cardiovascular events

    Time frame: Postoperative 7 days or before discharge

  9. Long-term survival

    Time frame: 30 days after surgery

    Survival information will be obtained through telephone follow-up.

  10. Long-term survival

    Time frame: 12 months after surgery

    Survival information will be obtained through telephone follow-up.

  11. Long-term sleep quality

    Time frame: 30 days after surgery

    The patients' sleep quality will be assessed through telephone follow-up using the Sleep Quality and Nighttime Restlessness Scale (SQNRS). The SQNRS score ranges from 0 to 10, with higher scores indicating better sleep quality.

  12. Long-term sleep quality

    Time frame: 12 months after surgery

    The patients' sleep quality will be assessed through telephone follow-up using the Sleep Quality and Nighttime Restlessness Scale (SQNRS). The SQNRS score ranges from 0 to 10, with higher scores indicating better sleep quality.

  13. Long-term pain

    Time frame: 30 days after surgery

    The patients' long-term pain will be assessed through telephone follow-up using the Visual Analogue Scale (VAS). A VAS score ranges from 0 to 10, with 1-3 indicating mild pain, 4-6 indicating moderate pain, and 7-10 indicating severe pain.

  14. Long-term pain

    Time frame: 12 months after surgery

    The patients' long-term pain will be assessed through telephone follow-up using the Visual Analogue Scale (VAS). A VAS score ranges from 0 to 10, with 1-3 indicating mild pain, 4-6 indicating moderate pain, and 7-10 indicating severe pain.

  15. Total hospitalization costs

    Time frame: 30 days after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Fuxia Yan

CONTACT

[email protected]

010 88396628

Sponsors and collaborators

Lead sponsor

Yan Fuxia

Other

Registry information

Official study title

Effect of Preoperative Sleep Intervention on Postoperative Delirium in Adult Patients Undergoing Cardiac Surgery: a Multicenter Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 15, 2025
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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