Transcutaneous Electrical Acupoint Stimulation of P6 to Prevent Postoperation Nausea and Vomiting (TEASP6PPONV)

October 9, 2015 updated by: Xiao-Yu Yang, MD, Huashan Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

157

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201907
        • Department of Anesthesiology, North Institute of Huashan Hospital,Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Transcutaneous electrical acupoint stimulation
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
Drug: Dexamethasone
will be given after induction
Active Comparator: Tropisetron
Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.
Drug: Dexamethasone
will be given after induction
Device: Sham transcutaneous electrical acupoint stimulation
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.
Drug: Tropisetron
will be given at the start of skin closure
Other Names:
  • Tropisetron Hydrocloride Injection
  • Batch number:131001
Sham Comparator: Control
Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.
Drug: Dexamethasone
will be given after induction
Device: Sham transcutaneous electrical acupoint stimulation
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.

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
Time Frame: within 24h after operation
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
Time Frame: within 24h after the operation
within 24h after the operation
Number of Participants Experiencing Postoperative Vomiting in 24h Postoperatively
Time Frame: within 24h after operation
including retching and vomiting
within 24h after operation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need of Postoperative Metoclopramide
Time Frame: within 48h after operation
the number of patients who needed metoclopramide as a rescue medicine postoperatively
within 48h after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huashan Hospital

Investigators

  • Study Chair: Jun Zhang, MD, PhD, Department of Anesthesiology, North Institute of Huashan Hospital,Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

March 24, 2014

First Submitted That Met QC Criteria

March 24, 2014

First Posted (Estimate)

March 26, 2014

Study Record Updates

Last Update Posted (Estimate)

October 12, 2015

Last Update Submitted That Met QC Criteria

October 9, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEAS-PONV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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