Transcutaneous Electrical Acupoint Stimulation of P6 to Prevent Postoperation Nausea and Vomiting

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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. An anesthesiologist and an anesthetic nurse, who are trained for the study and blinded to the randomization, will collect the data.

Official Title
-----------------
Transcutaneous Electrical Acupoint P6 Stimulation vs. Tropisetron Both in Combination With Dexamethasone to Prevent Postoperation Nausea and Vomiting in Women

Conditions
-----------------
Postoperative Nausea and Vomiting

Intervention / Treatment
-----------------
* Device: Transcutaneous electrical acupoint stimulation
* Device: Sham transcutaneous electrical acupoint stimulation
* Drug: Tropisetron
* Drug: Dexamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I or II aged between 18 to 60yr scheduled for elective gynecological laparoscopic surgery requiring general anesthesia Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acustimulation<br>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. | Device: Transcutaneous electrical acupoint stimulation<br>* A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.<br>* Other names: Electrical neuromuscular stimulation device,JNR-2;Drug: Dexamethasone<br>* will be given after induction<br>|
| Active Comparator: Tropisetron<br>Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction. | Device: Sham transcutaneous electrical acupoint stimulation<br>* The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.<br>Drug: Tropisetron<br>* will be given at the start of skin closure<br>* Other names: Batch number:131001;Drug: Dexamethasone<br>* will be given after induction<br>|
| Sham Comparator: Control<br>Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction. | Device: Sham transcutaneous electrical acupoint stimulation<br>* The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.<br>Drug: Dexamethasone<br>* will be given after induction<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Experiencing Postoperative Nausea and Vomiting in 24h Postoperatively | the total number including nausea, retching and vomiting within 24h after operation | within 24h after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Experiencing Postoperative Nausea in 24h Postoperatively |  | within 24h after the operation | 
| Number of Participants Experiencing Postoperative Vomiting in 24h Postoperatively | including retching and vomiting | within 24h after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative nausea and vomiting, Transcutaneous electrical acupoint stimulation, Gynecological laparoscopic surgery, Tropisetron, Dexamethasone