Effect of taVNS on Perioperative Anxiety in Major Abdominal Surgery

Официальное название

Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Perioperative Anxiety in Patients Undergoing Major Abdominal Surgery

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Incidence of perioperative anxiety [Срок оценки: From the day of surgery through 72 hours postoperatively following the completion of the intervention]

Вторичные конечные точки (10)

• Severity and scores of perioperative anxiety [Срок оценки: Within one month postoperatively]
• Severity and scores of perioperative depression [Срок оценки: Within one month postoperatively]
• Sleep Quality [Срок оценки: Within one month postoperatively]
• Pain intensity [Срок оценки: Within one month postoperatively]
• Incidence of postoperative delirium within the first 7 days after surgery [Срок оценки: Within 7 days postoperatively]
• Frailty score [Срок оценки: Within one month postoperatively]
• Quality of recovery [Срок оценки: Within one month postoperatively]
• Opioid consumption within the first 7 postoperative days [Срок оценки: Within 7 days postoperatively]
• Postoperative recovery: including time to first ambulation, time to first flatus, and time to first defecation [Срок оценки: up to 1 month]
• Length of hospital stay [Срок оценки: up to 1 month]

Критерии участия

Критерии включения

• Age: Between 18 and 85 years.
• 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.
• ASA classification I-III.

Критерии исключения

• Active skin breakdown, erythema, swelling, infection of the ear, or significant anatomical abnormalities of the external ear.
• Pre-existing bradycardia (resting heart rate < 50 beats/min) or third-degree atrioventricular block.
• Presence of a cardiac pacemaker or other active electronic implants.
• A documented history of traumatic brain injury within the past 6 months.
• Chronic pain or long-term reliance on analgesic medications.
• Severe neuropsychiatric disorders or chronic use of psychotropic medications, including corticosteroids, antidepressants, or anxiolytics.
• Severe cognitive impairment or any condition precluding effective communication or completion of the assessment scales.
• Women who were pregnant, lactating, or planning to conceive.
• Current enrollment in other interventional clinical trials.
• Anticipated direct transfer to the ICU immediately following surgery.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 4 центра

• Huzhou Central Hospital — Huzhou
• The Second Affiliated Hospital of Jiaxing University — Jiaxing
• Jiande First People's Hospital — Meicheng
• The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China. — Ханчжоу

Идентификаторы

NCT: NCT07495163 · 2026-0369

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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