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Heart Rate Variability Changes and Postoperative Delirium After Major Abdominal Surgery

NCT07783464 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2026-08-31

No results posted yet for this 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.

Conditions

  • Postoperative Delirium (POD)
  • Heart Rate Variability (HRV)

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.

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Eligibility

Min Age
65 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-04-30
Completion
2027-05-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07783464 on ClinicalTrials.gov