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Completed

NCT Number: NCT02096835

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology, North Institute of Huashan Hospital,Fudan University

Shanghai, Shanghai Municipality, 201907, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcutaneous electrical acupoint stimulation

Device

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.

Other names: TEAS, Electrical neuromuscular stimulation device,JNR-2

Sham Transcutaneous Electrical Acupoint Stimulation

Device

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.

tropisetron

Drug

will be given at the start of skin closure

Other names: Tropisetron Hydrocloride Injection, Batch number:131001

Dexamethasone

Drug

will be given after induction

Primary outcomes

  1. Number of Participants Experiencing Postoperative Nausea and Vomiting in 24h Postoperatively

    Time frame: within 24h after operation

    the total number including nausea, retching and vomiting within 24h after operation

Secondary outcomes

  1. Number of Participants Experiencing Postoperative Nausea in 24h Postoperatively

    Time frame: within 24h after the operation

  2. Number of Participants Experiencing Postoperative Vomiting in 24h Postoperatively

    Time frame: within 24h after operation

    including retching and vomiting

Other outcomes

  1. Need of Postoperative Metoclopramide

    Time frame: within 48h after operation

    the number of patients who needed metoclopramide as a rescue medicine postoperatively

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Official study title

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

Acronym: TEASP6PPONV

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Mar 26, 2014
Registry last updated
Oct 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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