Clinical trial NCT02096835: Transcutaneous Electrical Acupoint Stimulation of P6 to Prevent Postoperation Nausea and Vomiting
Official title: Transcutaneous Electrical Acupoint P6 Stimulation vs. Tropisetron Both in Combination With Dexamethasone to Prevent Postoperation Nausea and Vomiting in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Keywords: Postoperative nausea and vomiting
Transcutaneous electrical acupoint stimulation
Gynecological laparoscopic surgery
Tropisetron
Dexamethasone
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2014-03-26
Enrollment: 157
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of Participants Experiencing Postoperative Nausea and Vomiting in 24h Postoperatively
timeFrame: within 24h after operation
Secondary outcomes:
measure: Number of Participants Experiencing Postoperative Nausea in 24h Postoperatively
timeFrame: within 24h after the operation
measure: Number of Participants Experiencing Postoperative Vomiting in 24h Postoperatively
timeFrame: within 24h after operation
Other outcomes:
measure: Need of Postoperative Metoclopramide
timeFrame: within 48h after operation
Locations:
city: Shanghai
country: China
facility: Department of Anesthesiology, North Institute of Huashan Hospital,Fudan University
state: Shanghai
Study officials:
affiliation: Department of Anesthesiology, North Institute of Huashan Hospital,Fudan University
name: Jun Zhang, MD, PhD
role: STUDY_CHAIR
References:
citation: Yang XY, Xiao J, Chen YH, Wang ZT, Wang HL, He DH, Zhang J. Dexamethasone alone vs in combination with transcutaneous electrical acupoint stimulation or tropisetron for prevention of postoperative nausea and vomiting in gynaecological patients undergoing laparoscopic surgery. Br J Anaesth. 2015 Dec;115(6):883-9. doi: 10.1093/bja/aev352. Epub 2015 Oct 27.