Electroacupuncture for Pain Relief in Patients With Nasal Sinus Surgery and Mammaplasty: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- the mean infusion rate of intraoperative remifentanil and propofol
研究概览
简要总结
The purpose of this study is to verify the intraoperative analgesia of electroacupuncture in patients undergoing selective nasal sinus surgery and mammaplasty.
详细描述
Acupuncture therapy has been proved helpful in the patients suffering from various pain problems. And it is reported to be able to reduce the intraoperative anesthetic requirement. However, so far there is few evidence from randomized controlled studies to confirm the assistant anesthetic effect of acupuncture. Electroacupuncture (EA) is a modern non-invasive technique of traditional acupuncture. Compared to traditional acupuncture, EA is more practicable, more easily to be accepted by patients and operated by physicians. Nasal sinus surgery and mammaplasty, especially breast augmentation, mostly belong to the scope of day surgeries, which demand a rapid, smooth recovery from anesthesia with minimum adverse side effects (e.g.: pain, PONV, etc).
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 29 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •selective nasal sinus surgery
- •selective mammaplasty
- •patients who accept the follow-up and sign the informed consent
排除标准
- •emergent surgery
- •pregnant or breast-feeding women
- •coagulopathy
- •history of gastrointestinal ulcer
- •liver or renal dysfunction
- •enrollment in other clinical trials at the same time not reaching the primary endpoint and probably interference the present trial
结局指标
主要结局
the mean infusion rate of intraoperative remifentanil and propofol
时间窗: during operation
To investigate the operative time and total volume of remifentanil and propofol used during operation, and then calculate the mean infusion rate. To assess whether intraoperative requirements for anesthetic drugs could be reduced by EA pretreatment.
次要结局
- Visual analogue scale(post-operative 4h, 8h, 24h and 48h)
- Extubation time(postoperation)
研究者
wangqiang
Associate Professor, Associate Consultant
Xijing Hospital