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

Primary Purpose

Postoperative Nausea and Vomiting

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transcutaneous electrical acupoint stimulation
Sham transcutaneous electrical acupoint stimulation
Tropisetron
Dexamethasone
Sponsored by
Huashan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring Postoperative nausea and vomiting, Transcutaneous electrical acupoint stimulation, Gynecological laparoscopic surgery, Tropisetron, Dexamethasone

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Acustimulation

Tropisetron

Control

Arm Description

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 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.

Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Participants Experiencing Postoperative Nausea in 24h Postoperatively
Number of Participants Experiencing Postoperative Vomiting in 24h Postoperatively
including retching and vomiting

Full Information

First Posted
March 24, 2014
Last Updated
October 9, 2015
Sponsor
Huashan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02096835
Brief Title
Transcutaneous Electrical Acupoint Stimulation of P6 to Prevent Postoperation Nausea and Vomiting
Acronym
TEASP6PPONV
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

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huashan Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
Keywords
Postoperative nausea and vomiting, Transcutaneous electrical acupoint stimulation, Gynecological laparoscopic surgery, Tropisetron, Dexamethasone

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
157 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acustimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Tropisetron
Arm Type
Active Comparator
Arm Description
Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.
Intervention Type
Device
Intervention Name(s)
Transcutaneous electrical acupoint stimulation
Other Intervention Name(s)
TEAS, Electrical neuromuscular stimulation device,JNR-2
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham transcutaneous electrical acupoint stimulation
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Tropisetron
Other Intervention Name(s)
Tropisetron Hydrocloride Injection, Batch number:131001
Intervention Description
will be given at the start of skin closure
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
will be given after induction
Primary Outcome Measure Information:
Title
Number of Participants Experiencing Postoperative Nausea and Vomiting in 24h Postoperatively
Description
the total number including nausea, retching and vomiting within 24h after operation
Time Frame
within 24h after operation
Secondary Outcome Measure Information:
Title
Number of Participants Experiencing Postoperative Nausea in 24h Postoperatively
Time Frame
within 24h after the operation
Title
Number of Participants Experiencing Postoperative Vomiting in 24h Postoperatively
Description
including retching and vomiting
Time Frame
within 24h after operation
Other Pre-specified Outcome Measures:
Title
Need of Postoperative Metoclopramide
Description
the number of patients who needed metoclopramide as a rescue medicine postoperatively
Time Frame
within 48h after operation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Zhang, MD, PhD
Organizational Affiliation
Department of Anesthesiology, North Institute of Huashan Hospital,Fudan University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Anesthesiology, North Institute of Huashan Hospital,Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201907
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
26507494
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.
Results Reference
derived

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

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