An observational study in Postoperative Delirium (POD) and Heart Rate Variability (HRV), sponsored by The First Affiliated Hospital with Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 65 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Observational
Among 185 studies in Emergence Delirium with a site in China — 64 open to participants now, 65 under way, 1 of them phase 3. Emergence Delirium · China.
Among the 185 studies in Emergence Delirium with a site in China, this one is the 24th largest by planned enrollment of the 74 observational ones that give a count, is one of 25 that started in 2026, is one of 74 observational ones, reaches primary completion later than 49 of the 64 other live ones, and was the 179th registered.
752 studies on the registry are indexed under Emergence Delirium; 262 are open to participants now.
Browse Emergence Delirium studies →64 of the 185 studies in Emergence Delirium with a site in China are open now. Recruiting first, the newest first:
Nanjing First Hospital, Nanjing Medical University · Sites in China
Ages 65–90 · Healthy volunteers
Peking University First Hospital · Sites in China
Ages 65+ · Healthy volunteers
Peking University People's Hospital · Sites in China
Ages 65+ · Healthy volunteers
Fujian Medical University Union Hospital · Sites in China
Ages 18+
Xiangya Hospital of Central South University · Sites in China
Ages 60+
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 143 Emergence Delirium studies recruiting now, 79 (55%) set no upper age limit and 44 (31%) stop at 75 or younger; 34 take children under 18; 24 take healthy volunteers.
This study: 65 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
185 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 25 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 500 is above the median of 164 across 278 observational studies indexed under Emergence Delirium.
Median enrollment 225 across the 111 interventional studies, 300 across the 74 observational. Of the 74 that completed or were terminated, 2 (3%) have results posted.
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1 of 185 have an industry lead sponsor. The 10 most frequent:
The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 568 studies on the registry; 317 are open to participants now.
The First Affiliated Hospital with Nanjing Medical University has 2 studies filed under Emergence Delirium — fewer than ten, so there is no comparison to draw.
21 of the studies in Emergence Delirium with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06361238Phase 3The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolLiraglutide in Preventing Delirium in Diabetic Elderly After Cardiac Surgery | 2027-03-31 |
| NCT07880938The First Hospital of Jilin UniversityIntranasal Dexmedetomidine Combined With Esketamine for Emergence Quality After Suspension Laryngoscopy | 2026-12 |
| NCT07523334Peking University First HospitalImpact of Esketamine on Delayed Neurocognitive Recovery in Older Patients | 2026-12 |
| NCT07351474The First Affiliated Hospital with Nanjing Medical UniversityRemimazolam for Reducing Postoperative Delirium in Elderly Patients Undergoing Laparoscopic Gastrectomy | 2026-12-25 |
| NCT07394647The First Affiliated Hospital of Zhejiang Chinese Medical UniversityTranscutaneous Auricular Vagus Nerve Stimulation for Prevention of Emergence Agitation and Delirium in Children Undergoing Tonsillectomy and Adenoidectomy | 2026-12-30 |
Add all 21 to your calendar (.ics) → With an account.
Among the 185 studies in Emergence Delirium with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Postoperative delirium (POD) is a common neurocognitive complication following major surgery in older adults and is associated with increased morbidity, prolonged hospitalization, and adverse clinical outcomes. However, objective and easily obtainable biomarkers for early identification of patients at high risk of POD remain limited.
Heart rate variability (HRV) reflects autonomic nervous system regulation and may provide a non-invasive marker of physiological stress and impaired autonomic adaptability. Major abdominal surgery induces substantial systemic stress responses, including inflammation, neuroendocrine activation, and autonomic disturbances. Whether early postoperative alterations in HRV are associated with subsequent POD development remains unclear.
This is a single-center, prospective observational cohort study. Patients aged 65-85 years undergoing elective major abdominal surgery under general anesthesia will be consecutively enrolled. Baseline demographic characteristics, comorbidities, frailty status, cognitive function, and perioperative clinical variables will be collected.
Resting HRV will be measured at 10:00 AM on the day of surgery before anesthesia induction and again at the same time point on the first postoperative day using a validated heart rate monitoring device. HRV analysis will be performed based on standardized 5-minute recordings in accordance with established recommendations for short-term HRV assessment. Time-domain, frequency-domain, and nonlinear HRV parameters will be calculated.
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). Additional clinical outcomes include delirium severity, delirium duration, postoperative cognitive function, quality of recovery, postoperative nausea and vomiting, and length of hospital stay.
The primary objective is to evaluate the association between early postoperative HRV changes and the occurrence of POD after adjustment for clinically relevant confounding factors, including age, baseline cognitive function, frailty status, surgical duration, and baseline HRV. Secondary analyses will explore the relationship between representative HRV markers and postoperative clinical outcomes and assess their potential utility for early POD risk stratification.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Elderly patients undergoing elective major abdominal surgery under general anesthesia will be prospectively enrolled and followed for postoperative delirium.
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.
Occurrence of postoperative delirium within 7 days after surgery
Postoperative delirium will be assessed daily from postoperative day 1 to postoperative day 7 using the Chinese version of the 3-Minute Diagnostic Interview for CAM-defined Delirium (3D-CAM). Delirium diagnosis will be based on the Confusion Assessment Method (CAM) algorithm.
Time frame: Postoperative day 1 to postoperative day 7 after surgery
Severity of postoperative delirium
The severity of postoperative delirium will be assessed using the Delirium Rating Scale-Revised-98 (DRS-R-98) among patients who develop postoperative delirium. The DRS-R-98 scores range from 0 to 46, with higher scores indicating greater delirium severity (worse outcome).
Time frame: Postoperative day 1 to postoperative day 7 after surgery
Duration of postoperative delirium
The duration of postoperative delirium episodes will be recorded from the first diagnosis of delirium until resolution during the postoperative assessment period.
Time frame: Postoperative day 1 to postoperative day 7 after surgery
Change in cognitive function after surgery
Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). Scores range from 0 to 30, with higher scores indicating better cognitive function (better outcome).
Time frame: Postoperative day 7
Quality of recovery after surgery
Quality of recovery will be assessed using the 15-item Quality of Recovery Questionnaire (QoR-15). Scores range from 0 to 150, with higher scores indicating better quality of recovery (better outcome).
Time frame: Postoperative day 7
Plan to share: No — Individual participant data will not be shared with other researchers. The study involves detailed perioperative clinical information, heart rate variability data, and cognitive and delirium assessments collected from older surgical patients. Due to privacy protection, ethical considerations, and the absence of a predefined data-sharing plan in the informed consent process, individual participant data will not be made publicly available.
Started Sep 2026 (actual). Primary completion is estimated for Apr 2027, 7 months after the start.
Of 180 non-industry observational studies under Emergence Delirium, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 7 months is below that.
Counting every sponsor, half of 180 studies reached it within 21 months; a quarter within 10 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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The First Affiliated Hospital with Nanjing Medical University →