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

Not Applicable

Completed

Conditions: Postoperative Nausea and Vomiting

Interventions: Device: Transcutaneous electrical acupoint stimulation
Device: Sham transcutaneous electrical acupoint stimulation
Drug: Dexamethasone
Drug: Tropisetron

Registration Number: NCT02096835

Lead Sponsor: Huashan Hospital

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 157

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acustimulation	Dexamethasone	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.
Acustimulation	Transcutaneous electrical acupoint stimulation	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.
Tropisetron	Sham transcutaneous electrical acupoint stimulation	Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.
Tropisetron	Tropisetron	Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.
Control	Sham transcutaneous electrical acupoint stimulation	Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.
Tropisetron	Dexamethasone	Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.
Control	Dexamethasone	Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Postoperative Nausea and Vomiting in 24h Postoperatively	within 24h after operation	the total number including nausea, retching and vomiting within 24h after operation

Secondary Outcome Measures

Name	Time	Method
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	including retching and vomiting