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

Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Quality of Recovery After Major Noncardiac Surgery: A Randomized Trial.

This test will try whether non-invasive ear (transcutaneous auricular) vagus nerve stimulation given around the time of major noncardiac surgery helps adults recover better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 320 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Peking University First Hospital (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06957912 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18 to under 85 scheduled for elective or time-limited noncardiac surgery expected to last at least two hours who can communicate and cooperate with the intervention are ideal candidates.

Not a fit: Patients with ear skin lesions or infections, certain neurologic or cardiac conditions (including pacemaker or significant arrhythmias), prolonged expected postoperative intubation, or inability to cooperate are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, taVNS could shorten pain and gastrointestinal recovery and improve overall patient-reported quality of recovery after major noncardiac surgery.

How similar studies have performed: Small clinical and preclinical studies have reported promising effects of taVNS on pain, inflammation, sleep, and gastrointestinal recovery, but its perioperative use to improve overall quality of recovery after major noncardiac surgery remains relatively novel and not yet widely confirmed.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality

• 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

Conditions: Vagus Nerve Stimulation, Transcutaneous Electric Nerve Stimulation, Noncardiac Surgery, Quality of Recovery, Transcutaneous auricular vagus nerve stimulation, Noncardiac surgery, Quality of recovery