Effect of Preoperative Sleep Intervention on Postoperative Delirium in Adult Patients Undergoing Cardiac Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYan Fuxia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years.
Scheduled for elective coronary artery bypass grafting and/or valve surgery.
Preoperative Pittsburgh Sleep Quality Index (PSQI) score ≥ 5.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive behavioral therapy intervention
BehavioralThe 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 supplementPatients 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 interventionPatients 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).
Treatment groups
1,281 Participants
are divided into 3 treatment groupsGroup A: Placebo groupPlacebo comparator 1 intervention
Group B: Placebo and cognitive behavioral therapy intervention groupExperimental treatment 2 interventions
Group C: Melatonin and cognitive behavioral therapy intervention groupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
The incidence of postoperative delirium
Time frame
Postoperative 7 days or before dischargeSecondary outcomes
1
Postoperative sleep quality
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.
Time frame
Postoperative 7 days or before discharge2
Postoperative cognitive function
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.
Time frame
The 7th day after surgery or before discharge3
Duration and severity of delirium
Time frame
Postoperative 7 days or before discharge4
Postoperative mood and anxiety
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.
Time frame
The 7th day after surgery or before dischargeOther outcomes
1
Postoperative pain score
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.
Time frame
Postoperative 7 days or before discharge2
Types and doses of postoperative sedative and analgesic drugs
Time frame
Postoperative 7 days or before discharge3
Postoperative nausea and vomiting
The frequency of nausea and vomiting will be recorded daily for 7 days following surgery or before discharge, as documented during bedside consultations.
Time frame
Postoperative 7 days or before discharge4
Postoperative markers of oxidative stress and inflammation
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.
Time frame
24 hours after surgeryLocations
Sponsors and contacts
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Yan Fuxia
Lead sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor institution
Source ClinicalTrials.gov
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