Skip to content

Effect of Intraoperative Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Delirium and Negative Emotional States in Cardiac Surgery Patients

Effect of Intraoperative Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Delirium and Negative Emotional States in Cardiac Surgery Patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119919
Enrollment
Unknown
Registered
2026-03-05
Start date
2026-03-09
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 complications of the central nervous system

Interventions

Intervention group:Transcutaneous auricular vagus nerve stimulation (taVNS)

Sponsors

The First Medical Center of Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-85 years, regardless of gender. 2. Scheduled for elective cardiac surgery, including coronary artery bypass grafting, cardiac valve replacement/repair, combined coronary artery bypass grafting and valve replacement, etc. 3. New York Heart Association (NYHA) functional class I-III. 4. The patient or their authorized representative voluntarily signs the informed consent form, agrees to participate in this study, and cooperates with the completion of all observational indicators. 5. Surgery duration >= 2 hours, and the patient can tolerate the placement and stimulation of the transcutaneous auricular vagus nerve stimulation electrode during the procedure.

Exclusion criteria

Exclusion criteria: 1. Patients with other interfering factors affecting cognitive assessment, such as a preoperative MMSE score < 24; severe language, hearing, or visual impairments that cannot be compensated for with auxiliary means and thus hinder cooperation with assessments. 2. History of previously diagnosed delirium, dementia, Parkinson’s disease, schizophrenia, bipolar disorder, major depressive disorder, or other cognitive or psychiatric disorders; long-term use of psychotropic medications (e.g., antipsychotics, anxiolytics, antidepressants, sedative-hypnotics) that cannot be discontinued or adjusted. 3. Presence of skin lesions, infections, ulcers, keloids, severe dermatitis, or congenital deformities in both ears that prevent effective fixation of the taVNS electrodes; history of ear surgery or neural damage in the ear; allergy to taVNS electrode materials or conductive gel. 4. Concurrent severe cardiac arrhythmias; implantation of electronic devices such as cardiac pacemakers, implantable cardioverter-defibrillators, or deep brain stimulators. 5. Participation in other interventional clinical studies within the past 3 months; other circumstances deemed by the investigator as unsuitable for inclusion in the study.

Design outcomes

Primary

MeasureTime frame
The incidence of postoperative delirium;

Secondary

MeasureTime frame
The incidence of postoperative depression;The incidence of postoperative anxiety;sedation-agitation scale;Postoperative Pain;Postoperative sleep disorders;

Countries

China

Contacts

Public ContactMi Weidong

The First Medical Center of Chinese PLA General Hospital

haoxinyu19980206@163.com+86 133 8108 2966

Outcome results

None listed

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