A heartbeat clue to Post-Surgery confusion in seniors?
NCT ID NCT07783464
First seen Aug 24, 2026 · Last updated Sep 01, 2026 · Updated 5 times
Summary
This study looks at whether changes in heart rate variability (HRV) shortly after major abdominal surgery can help predict postoperative delirium—a state of confusion that can affect older patients. Researchers will measure HRV in 500 adults aged 65-85 before and within 24 hours after surgery, then track who develops delirium over the next week. The goal is to see if a simple, non-invasive heart monitor could serve as an early warning sign for this serious complication.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Perioperative heart rate variability monitoring
- What this could lead to
- If successful, this could lead to a simple, non-invasive way to identify older patients at higher risk of postoperative delirium, enabling earlier preventive care.
- What could go wrong
- This is an observational study, so it can only show associations, not cause and effect. The findings may not apply to all surgical patients or settings.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Older patients aged 65 to 85 years undergoing elective major abdominal surgery under general anesthesia will be prospectively enrolled. Perioperative heart rate variability will be assessed before surgery and within 24 hours after surgery, and participants will be followed for the occurrence of postoperative delirium during the first 7 postoperative days.
- Ages
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65 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029, China
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Other studies related to the condition(s) this trial covers.
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