Perioperative Percutaneous Electrical Nerve Stimulation Via a Wearable Equipment on Postoperative Nausea and Vomiting（PONV） in Patients Undergoing Laparoscopy Abdominal Surgery: a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 326
- 试验地点
- 1
- 主要终点
- Incidence of postoperative nausea and vomiting(PONV)
研究概览
简要总结
This study aims to certify the effectiveness of percutaneous electrical nerve stimulation at Pericardium 6 (PC6) via a wearable equipment during perioperative period on preventing postoperative nausea and vomiting.
详细描述
Introduction
This study aims to certify the effectiveness of percutaneous electrical nerve stimulation at Pericardium 6 (PC6) via a wearable equipment during perioperative period on preventing postoperative nausea and vomiting.
Method and analysis: A total of approximately 302 patients undergoing elective laparoscopic surgery will be enrolled. Participants will be randomly assigned to either a electrical stimulation group or a placebo group, with computer-generated randomization and concealed allocation using sealed envelopes. The electrical stimulation group will receive PC point electrical stimulation 30 minutes before surgery until 24 hours postoperatively, while the placebo group will wear a wristband without stimulation. The primary outcome will be the incidence of postoperative nausea and vomiting, with secondary outcomes including the incidence of nausea and vomiting within 24 hours after surgery, gastrointestinal and hemodynamic indices, postoperative recovery, hospital stay and cost, and complications.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18-65 years;
- •Patients undergoing elective laparoscopic surgery;
- •American Society of Anaesthesiologists(ASA) Grade 1 to 3;
- •Anesthesia: General Anesthesia, Tracheal Intubation;
- •BMI: ≥18, <28;
- •Gender: female
- •Patients or their family members are able to comprehend the study protocol and are willing to participate in this research by providing written informed consent.
排除标准
- •There are incisions or scars in the wearing position of the device;
- •There is a local infection in the wearing position of the device;
- •upper extremity nerve injury;
- •history of spinal cord surgery;
- •Participated in other clinical trials within 4 weeks;
- •suffering from severe central nervous system disease or mental disorder;
- •Patients need to return to the ICU after surgery.
研究组 & 干预措施
stimulation group
accept general drug prevention, wear the equipment, and receive electrical stimulation.
干预措施: antimetic drugs（ dexamethasone，ondansetron） (Drug)
control group
accept general drug prevention and wear the equipment but receive no electrical stimulation
干预措施: antimetic drugs（ dexamethasone，ondansetron） (Drug)
stimulation group
accept general drug prevention, wear the equipment, and receive electrical stimulation.
干预措施: electrical stimualtion via EmeTerm bracelet (Device)
结局指标
主要结局
Incidence of postoperative nausea and vomiting(PONV)
时间窗: 24 hours after surgery
Ask patients if they experienced nausea or vomiting 24 hours after surgery.
次要结局
未报告次要终点