Effect of taVNS on Perioperative Anxiety in Major Abdominal Surgery

NCT07495163 · tracked via the Priya Life Science China tracker

Sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine

Phase

Not applicable

Started

2026-05-01

Last updated

2026-05-19

Condition(s) studied

Perioperative AnxietyMajor Abdominal Surgery

Investigational drug(s) / intervention(s)

transauricular auricular vagus nerve stimulationtransauricular auricular vagus nerve stimulation

transauricular auricular vagus nerve stimulation: Patients will receive three taVNS sessions, with each session lasting 60 minutes.

transauricular auricular vagus nerve stimulation: Patients will receive three sham taVNS sessions, with each session lasting 60 minutes.

Study summary

It is reported that over 50% of patients undergoing major abdominal surgery experience perioperative anxiety, which often triggers a vicious cycle of "anxiety-pain-gastrointestinal dysfunction" and significantly hinders postoperative recovery. Existing pharmacological and psychological interventions are limited by adverse effects such as respiratory depression, paralytic ileus, and poor patient compliance. While transcutaneous auricular vagus nerve stimulation (taVNS) has shown promise as a non-invasive neuromodulation technique for chronic neuropsychiatric disorders, high-quality evidence regarding its application in anxiety-susceptible perioperative populations is still lacking. This multicenter, randomized, parallel-group, double-blind, sham-controlled trial aims to recruit 282 patients undergoing elective major abdominal surgery across four centers in Mainland China. Eligible participants will be randomized (1:1) to receive either taVNS or sham stimulation for 60 minutes daily from two days prior to surgery through the day of the operation. The primary outcome is the incidence of perioperative anxiety from the day of surgery to 72 hours postoperatively, while secondary outcomes include depression, sleep quality, pain intensity, postoperative delirium, frailty scores, quality of recovery, time to first flatus and defecation, and length of hospital stay.

Eligibility

Sex

ALL

Min age

18 Years

Max age

85 Years

Healthy volunteers

Inclusion Criteria: 1. Age: Between 18 and 85 years. 2. Patients undergoing elective major abdominal surgery under general anesthesia, with an anticipated operative duration of ≥ 2 hours and a predicted postoperative length of stay of ≥ 2 days. 3. ASA classification I-III. Exclusion Criteria: 1. Active skin breakdown, erythema, swelling, infection of the ear, or significant anatomical abnormalities of the external ear. 2. Pre-existing bradycardia (resting heart rate \< 50 beats/min) or third-degree atrioventricular block. 3. Presence of a cardiac pacemaker or other active electronic implants. 4. A documented history of traumatic brain injury within the past 6 months. 5. Chronic pain or long-term reliance on analgesic medications. 6. Severe neuropsychiatric disorders or chronic use of psychotropic medications, including corticosteroids, antidepressants, or anxiolytics. 7. Severe cognitive impairment or any condition precluding effective communication or completion of the assessment scales. 8. Women who were pregnant, lactating, or planning to conceive. 9. Current enrollment in other interventional clinical trials. 10. Anticipated direct transfer to the ICU immediately following surgery.

Primary outcome measure(s)

Incidence of perioperative anxiety — From the day of surgery through 72 hours postoperatively following the completion of the intervention
Incidence of perioperative anxiety from the day of surgery through 72 hours postoperatively, as assessed by the 14-item Hamilton Anxiety Rating Scale (HAMA-14).

Trial sites (4)

Facility	City	Region
Huzhou Central Hospital	Huzhou	Zhejiang
The Second Affiliated Hospital of Jiaxing University	Jiaxing	Zhejiang
Jiande First People's Hospital	Meicheng	Zhejiang
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.	Hangzhou	China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07495163 on ClinicalTrials.gov ↗ ← All trials in China