Acupuncture For Prevention Of Postoperative Nausea And Vomiting In Patients Undergoing Laparoscopic Cholecystectomy - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Incidence of postoperative nausea and vomiting
研究概览
简要总结
The purpose is to find out if intraoperative acupuncture performed by needling PC 6 and LI4 point bilaterally, and Yin Tang point will help reduce the incidence postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy when added to a prophylactic regimen consisting of ondansetron and dexamethasone. The hypothesis is that the addition of this acupuncture treatment to ondansetron and dexamethasone given for prophylaxis will help reduce the incidence of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy when compared to patients receiving ondansetron and dexamethasone without acupuncture.
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 (Participant, Outcomes Assessor)
盲法说明
Patient will be under general anesthesia when treatment provided. They will not know whether or not they received acupuncture treatment. Postoperative assessors will not know which group the patient is in.
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient ages 18-64
- •American Society of Anesthesiology Physical Status I, II or III
- •Patients scheduled to undergo laparoscopic cholecystectomy at Harris Health System Ben Taub Hospital
排除标准
- •Scheduled open cholecystectomy - excluded due to increased levels of pain in open procedures
- •Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and perioperative medications
- •Allergy to any of the standard anesthetic agents
- •Patient inability to properly communicate with investigators (language barrier, dementia, delirium, psychiatric disorder)
- •Patient or surgeon refusal
研究组 & 干预措施
Acupuncture
Group Acupuncture: Points PC 6 bilaterally, LI 4 bilaterally, and Yin Tang will be needled using Seirin L Type 0.25 X 40 mm needles. MH 6 is located 2 cun (a traditional Chinese unit of length) above the wrist crease in between the tendons of palmaris longus and flexor carpi radialis. LI 4 is in the middle of first and second metacarpal bones. Yin Tang is located between the eyebrows. All needles will be removed once skin closure begins, and before emergence and extubation.
干预措施: Acupuncture (Device)
Control
No acupuncture treatment provided
结局指标
主要结局
Incidence of postoperative nausea and vomiting
时间窗: Postoperative: 0-1 hours, 1-6 hours, 6-12 hours, 12-24 hours
Incidence of nausea and vomiting after surgery
次要结局
- Total opioids used(24 hours)
- Postoperative pain(24 hours)
研究者
Jaime Ortiz
Professor of Anesthesiology
Baylor College of Medicine