Ear-based vagus nerve stimulation to improve recovery after major noncardiac surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares perioperative transcutaneous auricular vagus nerve stimulation (taVNS) with a sham stimulation in adults having major noncardiac surgery. Surface electrodes are placed on the ear to stimulate the auricular branch of the vagus nerve around the time of surgery with the goal of modulating inflammation, pain, sleep, and gastrointestinal recovery. Outcomes focus on patient-centered quality of recovery measures rather than just traditional physiologic or mortality endpoints. The approach builds on prior work showing taVNS can alter inflammatory and pain pathways, and participants will receive either active or sham stimulation in the perioperative period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged ≥18 years but \<85 years.
2. Scheduled for elective or limited-time noncardiac surgery with expected duration ≥2 hours.

Exclusion Criteria:

1. Lesions or infections of the auricle skin.
2. Recent or long-term use of cholinergic or anticholinergic medications.
3. Neurosurgery.
4. Expected mechanical ventilation with intubation for ≥1 day after surgery.
5. Diagnosed schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis before surgery.
6. Preoperative left ventricular ejection fraction (LVEF) \<30%, or those with sick sinus syndrome, sinus bradycardia (heart rate \<50 beats per minute), atrioventricular block of grade II or above, or implanted pacemaker.
7. Inability to communicate due to coma, severe dementia, or language barrier before surgery, or unable to cooperate with intervention.
8. American Society of Anesthesiologists physical status grade \>IV, or estimated survival \<24 hours.

Where it's running

• Peking University First Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Dong-Xin Wang, MD, PhD — Peking University First Hospital
• Study coordinator: Dong-Xin Wang, MD, PhD
• Email: wangdongxin@hotmail.com
• Phone: 86(10) 83572784

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.