taVNS Reduces Postoperative Pain and Complications in Patients With Gastric and Intestinal Tumors: A Randomized, Double-Blind, Parallel-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Difference in VAS Score on Postoperative Day 1
研究概览
简要总结
Postoperative acute pain control in patients with gastrointestinal tumors is not satisfactory, and surgical complications including gastrointestinal dysfunction, gastrointestinal fistula, abdominal and gastrointestinal hemorrhage, peritonitis and abscess, are still important factors affecting surgical outcomes, postoperative recovery, hospital stay, and even perioperative mortality. The application of taVNS during the perioperative period can enhance or preserve vagal nerve function, which may protect important organ functions through multiple pathways such as alleviating pain and inflammatory responses caused by surgical trauma, improving gastrointestinal function, enhancing cardiovascular regulation, reducing postoperative nausea and vomiting, and accelerating postoperative recovery, thereby reducing postoperative complications and mortality.
详细描述
Subjects who met the inclusion criteria were enrolled in the clinical trial and received 2 interventions at the following times: the day before surgery, and the afternoon of the 1st day postoperatively (15:00-17:00), a total of 2 times. The intervention implementers used vagus nerve stimulation equipment to place electrodes in the tragus area of the outer ear of the subjects in the experimental group (taVNS group). The control group (sham stimulation group) was set to have a pulse width of 200 μs, a frequency of 1 Hz, and an initial current of 10 mA, which was gradually increased to the pain tolerance threshold of the subject, capped at 50 mA，last for one hour. The VAS scores before and after stimulation for 10 minutes were recorded.
2) ECG monitoring: Both groups were monitored with a dynamic ECG monitor during the intervention period, starting 10 minutes before stimulation and ending 10 minutes after stimulation. The SDNN (Standard Deviation of NN intervals) of the sinus rhythm was measured before and after stimulation for 10 minutes. A uniform standard was used for anesthesia induction and maintenance during surgery, and all patients used the same patient-controlled intravenous analgesia (PCIA) plan.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years, BMI 18-30 kg/m², ASA Ⅱ-Ⅲ, elective laparoscopic gastric or intestinal tumor surgery, expected surgical duration ≥2 hours, patient understands study content and signs informed consent form.
排除标准
- •Kidney replacement therapy, treatment for arrhythmias requiring treatment, dementia, severe bradycardia, orthostatic tachycardia syndrome, neuro-muscular disorders, auricular dermatitis, planned post-operative transfer to ICU
研究组 & 干预措施
taVNS
Set the pulse width to 200 microseconds, frequency to 30 Hz, and start the current at 10 mA. Gradually increase the current until the patient reaches their pain tolerance threshold, and cap it at 50 mA.
干预措施: taVNS (Device)
sham taVNS
Set the pulse width to 200 microseconds, frequency to 1 Hz, current to 10 mA and gradually increase it to the patient's pain tolerance threshold, capped at 50 mA.
干预措施: sham taVNS (Device)
结局指标
主要结局
Difference in VAS Score on Postoperative Day 1
时间窗: before and after each stimulus for 10 minutes
Difference in VAS Score on Postoperative Day 1
次要结局
- Postoperative Complication Rate(1 day before being discharged from the hospital)
- The QoR-15 scale scores on the 1st and 3rd days after surgery(1 day before the operation and the third day after the operation)
- The time of the first postoperative anal exhaust(On the third day after the operation)
- The effective number of pain relief pump presses(One day before being discharged from the hospital)
- Postoperative Salvage Analgesic Consumption of Opioid Equivalents(One day before being discharged from the hospital)
- Length of hospital stay(One day before being discharged from the hospital)
- Standard Deviation of NN intervals(10 minutes before and after each stimulus)
- Root Mean Square of the Successive Differences(10 minutes before and after each stimulus)