NCT02597842Unknown不适用
Efficiency of Transcutaneous Electrical Acupoint Stimulation(TEAS) With Single Acupoint or Two Acupoints for Postoperative Nausea and Vomiting in Laparoscopic Operation: A Single Center, Randomized, Double-blinded, Controlled Clinical Trial
wangqiang1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2015年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- The incidence of postoperative nausea and vomiting
研究概览
简要总结
This is a single center, randomized, double-blinded, controlled clinical trial.The purpose of this study is to compare the effect of TEAS pretreatment with single acupoint or two acupoints for postoperative nausea and vomiting in patients undergoing laparoscopic operation.
详细描述
Patients were randomly assigned to four groups, receiving TEAS 30 minutes before induction.The stimulation was applied until the end of the operation. Postoperative nausea and vomiting was recorded 30 minute, 2 hour, 6 hour and 24 hour after the operation. The adverse events were recorded as well.
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
- Double (Investigator, 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
- 否
入选标准
- •Aged 18 to 65 years old
- •Scheduled for general anesthesia
- •BMI index is between 18 to 30
- •Informed consented
排除标准
- •Hypertension that is not controlled
- •Severe hepatic or renal dysfunction
- •Ever had received electrical stimulation treatment
- •Severe systemic infection
- •With contraindications to the use of TEAS, such as skin damage or infection at the acupoints
- •For any reason one can not cope with the studies, such as the following:
- •language comprehension, mental illness
- •Participate in the other clinical trial 3 month before the enrollment
结局指标
主要结局
The incidence of postoperative nausea and vomiting
时间窗: within 24 hours after operation
次要结局
- Change of concentration of serum 5-HT(intraoperative)
- Change of concentration of serum dopamine(intraoperative)
- Incidence of other postoperative complications(30minutes, 2hours, 6hours and 24 hours after operation)
- Postoperative nausea and vomiting（PONV） score(30minutes, 2hours, 6hours and 24 hours after operation)
- Visual Analogue Scale (VAS) pain score in PACU(30 minutes after operation)
研究者
wangqiang
Professor
Xijing Hospital
研究点 (1)
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