Effect of Transcutaneous Electrical Acupoint Stimulation on Remifentanil Consumption and Postoperative Pain in Patients Undergoing Radical Mastectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 153
- 主要终点
- consumption of remifentanil
研究概览
简要总结
Transcutaneous electrical acupoint stimulation (TEAS) has been shown to decrease the need of opioids including remifentanil during anaesthesia. However, it is not clear whether combination of two or more acupoints could induce stronger analgesia. Moreover, evidence for the long-term effect of TEAS has been limited. The present study was to compare the short-term and long-term effect on pain of dual-acupoint and single-acupoint TEAS.
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 (Care Provider, Investigator, Outcomes Assessor)
盲法说明
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 anesthesiologists to the group allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 to 65 yrs
- •body mass index (BMI) of 18 to 30 kg/m2
- •elective radical mastectomy under general anaesthesia
排除标准
- •contradictions to TEAS
- •difficulties in communication
- •histories of general anaesthesia
- •drug or alcohol abuse or addiction
- •cardiac dysfunction or severe hypertension
- •confirmed hepatic dysfunction and renal impairment
- •the participants recruited into other clinical trials during last three months
研究组 & 干预措施
single acupoint stimulation
干预措施: acupoint stimulation (Device)
single acupoint stimulation
干预措施: single acupoint (Device)
dual acupoints stimulation
干预措施: acupoint stimulation (Device)
dual acupoints stimulation
干预措施: dual acupoints (Device)
no stimulation
结局指标
主要结局
consumption of remifentanil
时间窗: from start of anesthesia to extubation, on average 2 hours
次要结局
- incidence of pain at 6m after surgery(from discharge from hospital to 6 months after surgery, approximately 3 months)
- respiratory depression(end of the surgery to discharge from postanesthesia care unit,with an average of 30 minutes)
- time to recall(from end of remifentanil infusion to patient response to verbal command,approximately 10 minutes on average)
- time to extubation(from end of remifentanil infusion to extubation,approximately 10 minutes on average)
- nausea and vomiting(end of the surgery to discharge from postanesthesia care unit,with an average of 30 minutes)
- visual analogue scale of pain(end of the surgery to discharge from postanesthesia care unit,with an average of 30 minutes)
- patients' satisfaction score(from end of surgery to 24 hours after surgery, totally 24 hours)
- incidence of pain at 3m after surgery(from discharge from hospital to 3 months after surgery, approximately 3 months)
研究者
Zhihong LU
principle investigator
Air Force Military Medical University, China