RecruitingNot ApplicableNCT06957912

Transcutaneous Auricular Vagus Nerve Stimulation and Quality of Recovery After Major Noncardiac Surgery

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

Sponsor

Peking University First Hospital

Enrollment

320 participants

Start Date

May 13, 2025

Study Type

INTERVENTIONAL

Conditions

Vagus Nerve Stimulation Transcutaneous Electric Nerve Stimulation

Summary

Transcutaneous auricular vagus nerve stimulation (taVNS) is a novel non-invasive neuromodulation technique. Existing evidence suggested that taVNS improves pain management, sleep quality, inflammatory responses, and gastrointestinal recovery after surgery. This study is designed to test the hypothesis that perioperative use of taVNS may improve quality of recovery in patients after major noncardiac surgery.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria2

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

Exclusion Criteria8

Lesions or infections of the auricle skin.
Recent or long-term use of cholinergic or anticholinergic medications.
Neurosurgery.
Expected mechanical ventilation with intubation for ≥1 day after surgery.
Diagnosed schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis before surgery.
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.
Inability to communicate due to coma, severe dementia, or language barrier before surgery, or unable to cooperate with intervention.
American Society of Anesthesiologists physical status grade \>IV, or estimated survival \<24 hours.

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Interventions

DEVICETranscutaneous auricular vagus nerve stimulation

Transcutaneous auricular vagus nerve stimulation is performed using earphone-shaped stimulators (tVNS501, Ruishenan Medical Device, Inc. JiangSu, China) on the left tragus areas of the outer ear for a total of 30 min. Using parameters we have identified through systematic review, electrical stimulation (pulse width: 200-300 μs; frequency: 25 Hz; duty cycles: 50%) is initiated at 200% perceptual threshold (PT) which means the minimum amount of electricity required to perceive electrical stimulation on the skin described as a pricking or tingling sensation. All conscious patients will be told they may or may not feel any sensation from the stimulation. The stimulation will be performed between 15:00 and 17:00 on the first day before surgery, at least 30 minutes before the start of surgery and between 08:00 and 10:00 on the first to third day after surgery.

DEVICESham stimulation

Sham stimulation is performed using earphone-shaped stimulators (tVNS501, Ruishenan Medical Device, Inc. JiangSu, China) on the left tragus areas of the outer ear for a total of 30 min. Using parameters we have identified through systematic review, electrical stimulation (pulse width: 200-300 μs; frequency: 25 Hz; duty cycles: 50%) is initiated at 200% perceptual threshold (PT) which means the minimum amount of electricity required to perceive electrical stimulation on the skin described as a pricking or tingling sensation. And the current will be automatically switched off after 15 s. All conscious patients will be told they may or may not feel any sensation from the stimulation. The stimulation will be performed between 15:00 and 17:00 on the first day before surgery, at least 30 minutes before the start of surgery and between 08:00 and 10:00 on the first to third day after surgery.