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

Postoperative Nausea and Vomiting Clinical Trial

— TEASP6PPONV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02096835
• Other study ID #: TEAS-PONV
• Status: Completed
• Phase: N/A
• First received: March 24, 2014
• Last updated: October 9, 2015
• Start date: January 2014
• Est. completion date: January 2015

Study information

• Verified date: October 2015
• Source: Huashan Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Science and Technology Commission of Shanghai Municipality
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

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.
• 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
• Dexamethasone
will be given after induction

Locations

Country	Name	City	State
China	Department of Anesthesiology, North Institute of Huashan Hospital,Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Need of Postoperative Metoclopramide	the number of patients who needed metoclopramide as a rescue medicine postoperatively	within 48h after operation	No
Primary	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	No
Secondary	Number of Participants Experiencing Postoperative Nausea in 24h Postoperatively		within 24h after the operation	No
Secondary	Number of Participants Experiencing Postoperative Vomiting in 24h Postoperatively	including retching and vomiting	within 24h after operation	No