Transcutaneous Electrical Acupoint P6 Stimulation vs. Tropisetron Both in Combination With Dexamethasone to Prevent Postoperation Nausea and Vomiting in Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- Number of Participants Experiencing Postoperative Nausea and Vomiting in 24h Postoperatively
研究概览
简要总结
The purpose of this study is to access the effect of TEAS of P6 in the prevention of PONV in women scheduled for gynecologic laparoscopic surgery with general anesthesia.
详细描述
150 female patients, aged between 18 to 60 y, who are scheduled for elective gynecological laparoscopic surgery requiring general anesthesia, will be randomly allocated by a computer generated randomization table to acustimulation group (Group Acu), tropisetron group (Group Trp),or dexamethasone group (Group Dxm).
In Group Acu, a surface electrode will be applied in the induction room to the P6 acupoint 30 min before induction.An operator will set electric stimulating current at 1mA with frequency at 2 Hz, and gradually increased the current intensity to a little below discomfort threshold.The stimulation will be maintained until the patient is discharged from the post-anesthesia care unit (PACU). In Group Trp and Group Dxm, the same protocol will be applied unless silicone covers attached to both electrodes.
A standardized anesthetic protocol will be followed. After induction, dexamethasone 10mg i.v. will be given in all groups. All patients will receive intravenous lactated Ringer's solution based on calculated preoperative deficits, surgical procedure, and estimated intraoperative blood loss. Parecoxib 40mg i.v. during surgery and incision infiltration of 0.5% ropivacaine at the end of surgery will be used for post-operative analgesia. After surgery, analgetic therapy will continue with morphine upon patient's request.After extubation, patients will be transported to PACU and observed for no less than 30 min. Metoclopramide 10mg i.v. will be administered as a rescue therapy to any patient who experiences an episode of moderate or severe nausea, an episode of vomiting, and requests rescue medication.
At the start of skin closure, a prefilled syringe which contains 5 ml of a solution will be administered intravenously to the patient. It will contain either saline (Group Acu and Group Dxm) or tropisetron 5mg (Group Trp).The syringe with the drug will be prepared by a study coordinator according to group allocation.
The patients, the anesthesiologists, and the nursing staff shall be unaware of the group assignments.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status I or II
- •aged between 18 to 60yr
- •scheduled for elective gynecological laparoscopic surgery requiring general anesthesia
排除标准
- •pregnancy or breastfeeding
- •mental retardation
- •psychiatric or neurological disease
- •use of antiemetics, emetogenic drugs, opioids or glucocorticosteroids within 3 days prior to surgery
- •known allergy to tropisetron or dexamethasone
- •nausea and/or vomiting within 24 hr prior to surgery
- •implantation of a cardiac pacemaker, cardioverter, or defibrillator
- •any skin problem at the acupoint stimulation area
研究组 & 干预措施
Acustimulation
Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.
干预措施: Transcutaneous electrical acupoint stimulation (Device)
Acustimulation
Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.
干预措施: Dexamethasone (Drug)
Tropisetron
Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.
干预措施: Sham transcutaneous electrical acupoint stimulation (Device)
Tropisetron
Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.
干预措施: Tropisetron (Drug)
Tropisetron
Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.
干预措施: Dexamethasone (Drug)
Control
Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.
干预措施: Sham transcutaneous electrical acupoint stimulation (Device)
Control
Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Number of Participants Experiencing Postoperative Nausea and Vomiting in 24h Postoperatively
时间窗: within 24h after operation
the total number including nausea, retching and vomiting within 24h after operation
次要结局
- Number of Participants Experiencing Postoperative Nausea in 24h Postoperatively(within 24h after the operation)
- Number of Participants Experiencing Postoperative Vomiting in 24h Postoperatively(within 24h after operation)