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Not yet recruiting NCT06777342

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

No phase Interventional Delirium - Postoperative Sleep Problems CABG Valve Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cognitive behavioral therapy intervention, Melatonin intervention, Placebo intervention.
Who it may be relevant to
Registry conditions: Delirium - Postoperative, Sleep Problems, CABG, Valve Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Behavioral Cognitive behavioral therapy intervention
    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 die
  • Dietary supplement Melatonin intervention
    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).
  • Other Placebo intervention
    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 outcome measures

  • The incidence of postoperative delirium [Time frame: Postoperative 7 days or before discharge]
Secondary outcome measures (4)
  • Postoperative sleep quality [Time frame: Postoperative 7 days or before discharge]
  • Postoperative cognitive function [Time frame: The 7th day after surgery or before discharge]
  • Duration and severity of delirium [Time frame: Postoperative 7 days or before discharge]
  • Postoperative mood and anxiety [Time frame: The 7th day after surgery or before discharge]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06777342 · 2024-2417

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗