Transcutaneous Electrical Acupoint Stimulation Decreases Remifentanil Consumption and Postoperative Pain in Patients Undergoing Radical Mastectomy: Dual Acupoints Versus Single Acupoint in a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- dose of remifentanil during anesthesia
研究概览
简要总结
The purpose of this study is to evaluate the effects of transcutaneous electric acupoint stimulation(TEAS) at single acupoint or dual acupoints on opioid consumption and postoperative pain in patients undergoing radical mastectomy
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
For all patients, electrodes were placed at the bilateral PC6 and RN17 and connected to the Hwato Electric Acupuncture Treatment Instrument. No patients in the study had previous experience of undergoing transcutaneous electrical stimulation treatment. Patients were told that they might or might not feel the electrical stimulation. Interventions were performed by a designated investigator who was not involved in the anaesthesia or the follow-up. The stimulator was placed in an opaque box to blind the surgical team and the anaesthetists to the group allocation.
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
- 否
入选标准
- •patients aged from 18 to 65 yrs
- •body mass index (BMI) of 18 to 30 kg/m2
- •elective radical mastectomy under general anesthesia
排除标准
- •contradictions to electric stimulation
- •difficulties in communication
- •histories of general anesthesia, drug or alcohol abuse or addiction
- •cardiac dysfunction or severe hypertension, confirmed hepatic dysfunction and renal impairment
- •participants recruited into other clinical trials during last three months
结局指标
主要结局
dose of remifentanil during anesthesia
时间窗: from start of anesthesia to extubation, on average 2 hours
次要结局
- incidence of respiratory depression during recovery(from extubation to discharge from post anesthesia care unit, approximately 40 minutes on average)
- visual analogue scale during recovery(from arriving to discharge from post anesthesia care unit, approximately 30 minutes on average)
- pain score at 6 months after surgery(from discharge from hospital to 6 months after surgery, approximately 3 months)
- time to extubation(from end of remifentanil infusion to extubation,approximately 10 minutes on average)
- incidence of nausea and vomiting during recovery(from extubation to discharge from post anesthesia care unit, approximately 40 minutes on average)
- time to recall(from end of remifentanil infusion to patient response to verbal command,approximately 10 minutes on average)
- visual analogue scale at 24 hour after surgery(from end of surgery to 24 hours after surgery, totally 24 hours)
- pain score at 3 months after surgery(from discharge from hospital to 3 months after surgery, approximately 3 months)
研究者
wangqiang
Professor
Xijing Hospital