Evaluation of PC 6 "Neiguan" With Conventional Acupuncture to Prevent PONV After Laparoscopic Cholecystectomy.
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Vomiting and Nausea
研究概览
简要总结
Assessment of the effectiveness of PC 6 "Neiguan" with conventional acupuncture for preventing PONV (PostOperative Nausea and Vomiting) after laparoscopic surgery.
详细描述
Utilizing acustimulation, the effect of PC 6 "Neiguan" (acupuncture point Pericardium 6) has been studied in PONV . Conventional acupuncture has not been tested yet in laparoscopic cholecystectomy.
The incidence of postoperative vomiting during the first 24 hours is the main outcome. Secondary outcomes include: complete response rate, total rescue ondansetron dose used and patient satisfaction with PONV management.
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)
盲法说明
The care provider get's an envelope from the study nurse when going to the patient in the operating room. Only the study nurse knows if an acupuncture needle is in the envelope.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male patients
- •General anesthesia
- •Undergoing laparoscopic surgery
- •Patient with American Society of Anesthesiologists physical status I-II
- •Written informed consent
排除标准
- •Pregnant women and breastfeeding
- •Patient with cardiac disease
- •Surgery more than 2 h
- •No bowel surgery
- •Signs of skin infection at or near the purposed site of the acupuncture point
- •Patient with American Society of Anesthesiologists physical status IIII-IV
研究组 & 干预措施
stimulation of the acupuncture point
a acupuncture needle and bandage will be applied at pericardium channel 6, point "Neiguan"
干预措施: stimulation (Other)
no stimulation of the acupuncture point
only a bandage will be applied at pericardium channel 6, point "Neiguan"
干预措施: no stimulation (Other)
结局指标
主要结局
Vomiting and Nausea
时间窗: 24 hours
numeric from 0-4, 0= no vomiting, 1= nausea, 2= moderate, 3= multiple and 4= extensive
次要结局
- Use of antiemetic(24 hours)
- Use of analgesia(24 hours)
研究者
Veerle Van Mossevelde
Data Nurse
Universitair Ziekenhuis Brussel