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

NCT02096835 | Completed Results DMC

• 1 other identifier: TEAS-PONV
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Nausea and Vomiting

Keywords

Postoperative nausea and vomiting; Transcutaneous electrical acupoint stimulation; Gynecological laparoscopic surgery; Tropisetron; Dexamethasone

Outcome Measures

Primary Outcomes (1)

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

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

  within 24h after operation

Secondary Outcomes (2)

• 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

Other Outcomes (1)

• Need of Postoperative Metoclopramide

  within 48h after operation

Study Arms (3)

Acustimulation

EXPERIMENTAL

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; Drug: Dexamethasone

Tropisetron

ACTIVE COMPARATOR

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

Device: Sham transcutaneous electrical acupoint stimulation; Drug: Tropisetron; Drug: Dexamethasone

Control

SHAM COMPARATOR

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

Device: Sham transcutaneous electrical acupoint stimulation; Drug: Dexamethasone

Interventions

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.

Also known as: TEAS, Electrical neuromuscular stimulation device,JNR-2

Acustimulation

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.

Control; Tropisetron

Tropisetron DRUG

will be given at the start of skin closure

Also known as: Tropisetron Hydrocloride Injection, Batch number:131001

Tropisetron

Dexamethasone DRUG

will be given after induction

Acustimulation; Control; Tropisetron

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I or II
• aged between 18 to 60yr
• scheduled for elective gynecological laparoscopic surgery requiring general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 201907, China

Location

Related Publications (1)

• 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.

  PMID: 26507494 DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Tropisetron; Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Dr.Xiaoyu Yang
• Organization: Huashan Hospital Fudan University Shanghai, China

yangxiaoyu@huashan.org.cn

086-021-52889999

Study Officials

• Jun Zhang, MD, PhD

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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD.

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: March 26, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: October 12, 2015
• Results First Posted: April 10, 2015

Record last verified: 2015-10

Locations

CN (1)