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Intervention Effect of Transcutaneous Ear Vagus Nerve Stimulation on Postoperative Delirium in Gastrointestinal Surgery Patients and Analysis of Intraoperative EEG Characteristics: A Randomized Controlled Trial

Intervention Effect of Transcutaneous Ear Vagus Nerve Stimulation on Postoperative Delirium in Gastrointestinal Surgery Patients and Analysis of Intraoperative EEG Characteristics: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119923
Enrollment
Unknown
Registered
2026-03-05
Start date
2026-03-05
Completion date
Unknown
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative delirium

Interventions

Experimental group:The experimental group received percutaneous auricular vagus nerve stimulation intervention during the perioperative period. The stimulation site was the vagus nerve distribution ar
Control group:The control group received sham stimulation at the same time points and locations, with identical stimulation protocols and electrode placement as the experimental group, but without gen

Sponsors

The Second Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 65 years, scheduled for elective gastrointestinal tumor surgery; 2. ASA physical status classification of I–III; 3. Preoperatively determined to be cooperative for assessment via educationally adjusted MMSE and clinical evaluation, with no moderate/severe cognitive impairment; 4. Signed informed consent and voluntarily participated in the study.

Exclusion criteria

Exclusion criteria: 1. Implantation of cardiac pacemakers, implantable cardioverter-defibrillators, deep brain stimulators, or other electronic/magnetic devices within the body; 2. History of epilepsy diagnosis or seizures within the past 6 months; history of cerebrovascular disease (such as cerebral infarction or cerebral hemorrhage); 3. Severe/unstable cardiovascular disease (e.g., myocardial infarction within the past 3 months, progressive heart failure, resting heart rate 7 points); 6. Currently using potent sedatives, antipsychotics, or potent anticholinergic drugs that cannot be maintained at stable levels during the study period; 7. Participation in other clinical trials or receipt of taVNS/invasive VNS therapy within the past 2 weeks prior to enrollment; 8. Individuals with infectious diseases, such as hepatitis B, syphilis, etc.

Design outcomes

Primary

MeasureTime frame
Postoperative delirium incidence rate;Perioperative EEG Parameters;

Secondary

MeasureTime frame
Intraoperative Inflammatory and Neurological Markers;Time required for gastrointestinal function recovery after surgery;Changes in Sleep Quality After Surgery;Anxiety and Depression State;Postoperative Pain Score;Incidence of adverse events and serious adverse events;

Countries

China

Contacts

Public ContactHua Fuzhou

The Second Affiliated Hospital of Nanchang University

huafuzhou@126.com+86 151 7023 8929

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026