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Clinical Trials in China / NCT07783464
Starting soon Observational

Heart Rate Variability Changes and Postoperative Delirium After Major Abdominal Surgery

NCT07783464 · tracked via the Priya Life Science China tracker
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Phase
Observational
Started
2026-09-01
Last updated
2026-08-31

Condition(s) studied

Postoperative Delirium (POD)Heart Rate Variability (HRV)

Investigational drug(s) / intervention(s)

Perioperative Heart Rate Variability Changes

Perioperative Heart Rate Variability Changes: Heart rate variability will be measured using standardized 5-minute recordings at predefined time points: 10:00 AM on the day of surgery before surgery and 10:00 AM on postoperative day 1 (within 24 hours after surgery). Perioperative changes in heart rate variability will be evaluated as an observational exposure to investigate their association with postoperative delirium in older patients undergoing elective major abdominal surgery under general anesthesia.

Study summary

This prospective observational cohort study aims to investigate whether early postoperative changes in heart rate variability (HRV) relative to baseline are associated with the development of postoperative delirium (POD) in older patients undergoing elective major abdominal surgery under general anesthesia. Patients aged 65-85 years will be enrolled. Resting HRV will be measured at 10:00 AM on the day of surgery before anesthesia induction and at the same time point on the first postoperative day using a validated heart rate monitoring device. HRV parameters will be derived from standardized 5-minute recordings. Changes in HRV parameters from baseline will be calculated, and their associations with POD occurrence will be evaluated. Postoperative delirium will be assessed daily from 24 hours after surgery to postoperative day 7, using the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM). The study will also explore the potential utility of HRV-derived markers for early POD risk stratification. Approximately 500 participants will be enrolled.

Eligibility

Sex
ALL
Min age
65 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria 1. Patients admitted to Jiangsu Provincial People's Hospital who are scheduled to undergo elective major abdominal surgery under general anesthesia. 2. Older patients aged 65 to 85 years. 3. Expected postoperative hospital stay of ≥7 days. 4. Body mass index (BMI) between 18.5 and 28.0 kg/m². 5. American Society of Anesthesiologists (ASA) physical status classification I-III. 6. Patients who are conscious, mentally competent, and able to cooperate with heart rate variability (HRV) measurements, questionnaire assessments, and follow-up evaluations. 7. Patients who voluntarily participate in the study and provide written informed consent. Exclusion Criteria 1. Patients with ASA physical status classification ≥IV or patients with end-stage cancer. 2. Patients with implanted cardiac pacemakers, implantable cardioverter-defibrillators, or other electronic devices that may interfere with ECG signal acquisition. 3. Patients with severe or unstable cardiovascular diseases, including but not limited to acute coronary syndrome, symptomatic bradycardia, sick sinus syndrome, second-degree or higher atrioventricular block, atrial fibrillation, atrial flutter, frequent premature beats, or other arrhythmias that may affect heart rate variability analysis. 4. Patients with diseases affecting autonomic nervous system function, including confirmed primary or secondary autonomic dysfunction, such as Parkinson's disease, multiple system atrophy, severe diabetic autonomic neuropathy, severe peripheral neuropathy, poorly controlled hyperthyroidism or hypothyroidism, and systemic amyloidosis. 5. Patients with a history of organic central nervous system diseases or psychiatric disorders, including major traumatic brain injury, stroke (ischemic or hemorrhagic), intracranial mass lesions, epilepsy, schizophrenia, bipolar disorder, major depressive disorder, or other severe psychiatric disorders. 6. Patients with severe baseline cognitive impairment or inability to complete cognitive assessments, including any of the following: (1) preoperative baseline Montreal Cognitive Assessment (MoCA) score \<14 points; (2) previously diagnosed dementia, preoperative delirium, coma, or other severe disturbances of consciousness; or (3) inability to complete standardized cognitive assessments due to severe visual impairment, hearing impairment, language barriers, or other causes. 7. Patients unable to undergo HRV measurement within 24 hours after surgery, including those with severe perioperative complications, emergency reoperation, extremely unstable vital signs, or requiring continuous deep sedation after surgery. 8. Patients who have taken anticholinergic medications, beta-blockers, antiarrhythmic drugs, or other medications that may significantly affect autonomic function within 1 month before study enrollment. 9. Patients who are currently participating in any other clinical trial.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital with Nanjing Medical University Nanjing Jiangsu

More The First Affiliated Hospital with Nanjing Medical University trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07783464 on ClinicalTrials.gov ↗ ← All trials in China