跳至主要内容
临床试验/NCT06957912
NCT06957912招募中不适用

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

Peking University First Hospital1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2025年5月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
320
试验地点
1
主要终点
Quality of recovery scores at 24 hours after surgery

研究概览

简要总结

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.

详细描述

The evolution of quality improvement initiatives, such as Enhanced Recovery After Surgery (ERAS) protocols, has shifted perioperative management paradigms toward prioritizing patient-centered subjective experiences such as quality of recovery over traditional outcomes such as mortality, morbidity, or physiological parameter recovery. Poor quality of recovery after surgery not only diminishes patient satisfaction but also correlates with increased 30-day postoperative complications, prolonged hospital stays, and elevated medical expenses.

The vagus nerve is a major component of the parasympathetic nervous system and is a critical relay for neuro-metabolic signals between the abdominal viscera and the brain. The ear is the only area where the vagus nerve is distributed on the body surface, and the auricular branch of the vagus nerve can project to nerve centers such as nucleus of solitary tract in the brainstem and the nucleus coeruleus in the midbrain.

Transcutaneous auricular vagus nerve stimulation (taVNS) can stimulate the auricular branch of the vagus nerve through surface electrodes located in the cymba conchae, and thus activate the vagus nerve circuit, regulate the activity of the brainstem, thalamus, and other brain regions, and regulate the related peripheral organs. Available evidences showed that taVNS reduces inflammatory response to surgery through cholinergic anti-inflammatory pathways, improves analgesia by reducing inflammation and activating serotonin and endorphins analgesic pathways, and promotes gastrointestinal function by regulating peristalsis and secretion of the digestive system; it was also found effective in improving sleep quality and relieving anxiolytic and depressive symptoms. The use of taVNS is relative safe; the incidence of adverse event is low and mainly included transient earache, headache, and local tingling, with no causal association to serious adverse events.

The investigators hypothesize that the application of taVNS in patients undergoing major noncardiac surgery may improve early postoperative quality of recovery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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.

研究组 & 干预措施

Transcutaneous auricular vagus nerve stimulation group

Experimental

Transcutaneous auricular vagus nerve stimulation

干预措施: Transcutaneous auricular vagus nerve stimulation (Device)

Sham stimulation group

Placebo Comparator

Sham stimulation

干预措施: Sham stimulation (Device)

结局指标

主要结局

Quality of recovery scores at 24 hours after surgery

时间窗: At 24 hours after surgery

Quality of recovery is assessed using the 15-item Quality of Recovery (QoR-15) Scale. The QoR-15 is a valid, reliable, responsive, and simple-to-use measure that can be applied across a broad range of surgical settings. The scale contains 15 questions that measure five dimensions of patient's health, including: physical comfort, emotional state, physical independence, psychological support, and pain, with scores ranging from 0 (the poorest quality of recovery) to 150 (the best quality of recovery).

次要结局

  • Quality of recovery scores at 48 and 72 hours after surgery(At 48 and 72 hours after surgery)
  • Pain intensity both at rest and with movement after surgery(Up to 3 days after surgery.)
  • Subjective sleep quality after surgery(Up to 3 days after surgery.)
  • Opioid consumption within 3 days after surgery(Up to 3 days after surgery.)
  • Pain intensity and opioid consumption (PIOC) index within 3 days after surgery.(Up to 3 days after surgery.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dong-Xin Wang

Professor and Chairman, Department of Anesthesiology

Peking University First Hospital

研究点 (1)

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