Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Opioid Consumption 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
- 108
- 主要终点
- Total consumption of opioids
研究概览
简要总结
This study aims to design a prospective, double-blind, randomized controlled trial to compare the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on postoperative visceral pain in patients undergoing major abdominal surgery. Participants will be randomly assigned to receive either taVNS or sham stimulation. The total consumption of opioids and other analgesics within 24 hours post-surgery in the AICU will be recorded, along with follow-up assessments of pain scores and quality of recovery scores (Qor-15) at 24 hours postoperatively.
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
- •Age between 18 and 85 years, regardless of gender
- •ASA physical status classification I-III
- •Scheduled for elective major abdominal surgery under general anesthesia, with postoperative admission to the AICU for monitoring
- •Anticipated duration of stay in the AICU is approximately 24 hours
排除标准
- •History of vagus nerve-related diseases (such as vasovagal syncope);
- •Severe arrhythmias or implanted electronic devices such as pacemakers;
- •Skin lesions, infections, or deformities at the site of external ear stimulation;
- •Long-term preoperative use of opioid medications or sedatives;
- •Allergy to study-related medications;
结局指标
主要结局
Total consumption of opioids
时间窗: within 24 hours postoperatively.
Total consumption of opioids (morphine equivalent) within 24 hours postoperatively.
次要结局
- The incidence of opioid-related complications(within 24 hours post-surgery)
- sleep quality score(Postoperative first-night)
- Quality of Recovery Score(24 Hours Post-Operatively)
- Adverse events associated with taVNS(24 Hours Postoperatively)
- The incidence of opioid-related complications(within 24 hours post-surgery)
研究者
Qing-he Zhou
Clinical Professor
Affiliated Hospital of Jiaxing University