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NOT YET RECRUITING
NCT07783464

Heart Rate Variability Changes and Postoperative Delirium After Major Abdominal Surgery

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

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.

Official title: Predictive Value of Early Postoperative Heart Rate Variability Changes From Baseline for Postoperative Delirium in Older Adults Undergoing Major Abdominal Surgery: A Prospective Cohort Study

Key Details

Gender

All

Age Range

65 Years - 85 Years

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2026-09-01

Completion Date

2027-05-15

Last Updated

2026-08-24

Healthy Volunteers

No

Interventions

OTHER

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.

Locations (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China