Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Perioperative Anxiety in Patients Undergoing Major Abdominal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 282
- 试验地点
- 4
- 主要终点
- Incidence of perioperative anxiety
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, 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
- •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.
排除标准
- •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.
研究组 & 干预措施
sham group
Participants in the sham group will receive 60-minute sham stimulation sessions daily, starting from two days preoperatively and continuing through the day of surgery, for a total of three sessions.
干预措施: transauricular auricular vagus nerve stimulation (Device)
taVNS group
Participants in the taVNS group will receive 60-minute stimulation sessions daily, starting from two days preoperatively and continuing through the day of surgery, for a total of three sessions.
干预措施: transauricular auricular vagus nerve stimulation (Device)
结局指标
主要结局
Incidence of perioperative anxiety
时间窗: 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).
次要结局
- Severity and scores of perioperative anxiety(Within one month postoperatively)
- Severity and scores of perioperative depression(Within one month postoperatively)
- Sleep Quality(Within one month postoperatively)
- Pain intensity(Within one month postoperatively)
- Incidence of postoperative delirium within the first 7 days after surgery(Within 7 days postoperatively)
- Frailty score(Within one month postoperatively)
- Quality of recovery(Within one month postoperatively)
- Opioid consumption within the first 7 postoperative days(Within 7 days postoperatively)
- Postoperative recovery: including time to first ambulation, time to first flatus, and time to first defecation(up to 1 month)
- Length of hospital stay(up to 1 month)
研究者
yu lina
Chief Physician
Second Affiliated Hospital, School of Medicine, Zhejiang University