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

Launched by YAN FUXIA · Jan 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether improving sleep before heart surgery can help prevent a condition called postoperative delirium, which can cause confusion and other problems after surgery. The trial will include adult patients who are scheduled for heart surgeries like coronary artery bypass grafting or valve surgery and who also have sleep issues. Participants will be randomly assigned to one of three groups: one will receive a placebo (a harmless substance), another will receive a placebo plus therapy to help with their sleep, and the third will receive melatonin (a sleep aid) plus the therapy. The main goal is to see if these sleep interventions can lower the chances of experiencing delirium after surgery.

To be eligible for the trial, participants must be at least 18 years old, scheduled for elective heart surgery, and have a certain level of sleep problems as indicated by a sleep quality questionnaire. However, individuals with certain medical histories, including severe neurological conditions or those currently taking specific medications for sleep, will not be able to participate. Participants can expect close monitoring of their sleep quality, cognitive function, and any delirium symptoms in the week following their surgery. This study aims to find effective ways to help patients recover better after heart surgery by addressing their sleep issues beforehand.

Gender

ALL

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.