Transcutaneous Electrical Acupoint Stimulation(TEAS) for Postoperative Nausea and Vomiting in Laparoscopic Operation

November 4, 2015 updated by: wangqiang

Efficiency of Transcutaneous Electrical Acupoint Stimulation(TEAS) With Single Acupoint or Two Acupoints for Postoperative Nausea and Vomiting in Laparoscopic Operation: A Single Center, Randomized, Double-blinded, Controlled Clinical Trial

This is a single center, randomized, double-blinded, controlled clinical trial.The purpose of this study is to compare the effect of TEAS pretreatment with single acupoint or two acupoints for postoperative nausea and vomiting in patients undergoing laparoscopic operation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients were randomly assigned to four groups, receiving TEAS 30 minutes before induction.The stimulation was applied until the end of the operation. Postoperative nausea and vomiting was recorded 30 minute, 2 hour, 6 hour and 24 hour after the operation. The adverse events were recorded as well.

Study Type

Interventional

Enrollment (Anticipated)

180

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 Contact

Study Contact Backup

  • Name: Zhihong Lu, M.D.;Ph D
  • Phone Number: 029-84775343
  • Email: deerlu@163.com

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital, Fourth Military Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lize Xiong, M.D., Ph.D.
        • Principal Investigator:
          • Qiang Wang, M.D., Ph.D.
        • Sub-Investigator:
          • Zhihong Lu, M.D., Ph.D.
        • Sub-Investigator:
          • Haifeng Duan
        • Sub-Investigator:
          • Tingting Liu

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. ASA I-III
  2. Aged 18 to 65 years old
  3. Scheduled for general anesthesia
  4. BMI index is between 18 to 30
  5. Informed consented

Exclusion Criteria:

  1. ASA IV
  2. Hypertension that is not controlled
  3. Severe hepatic or renal dysfunction
  4. Ever had received electrical stimulation treatment
  5. Severe systemic infection
  6. With contraindications to the use of TEAS, such as skin damage or infection at the acupoints

  7. For any reason one can not cope with the studies, such as the following:

    language comprehension, mental illness

  8. Participate in the other clinical trial 3 month before the enrollment

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: shuangxuezu
Patients were given 30min of TEAS before induction until the end of the operation at two acupoints.
Device: TEAS (transcutaneous electrical acupoint stimulation)
Electric stimulation was given through electrode attached to specific acupoints
Experimental: neiguanxuezu
Patients were given TEAS at neiguan acupoint.
Device: TEAS (transcutaneous electrical acupoint stimulation)
Electric stimulation was given through electrode attached to specific acupoints
Experimental: zusanlixuezu
Patients were given TEAS at Zusanli acupoint.
Device: TEAS (transcutaneous electrical acupoint stimulation)
Electric stimulation was given through electrode attached to specific acupoints
Sham Comparator: duizhaozu
Patients were not given TEAS at two acupoints.
Device: TEAS (transcutaneous electrical acupoint stimulation)
Electric stimulation was given through electrode attached to specific acupoints

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of postoperative nausea and vomiting
Time Frame: within 24 hours after operation
within 24 hours after operation

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of other postoperative complications
Time Frame: 30minutes, 2hours, 6hours and 24 hours after operation
30minutes, 2hours, 6hours and 24 hours after operation
Postoperative nausea and vomiting（PONV） score
Time Frame: 30minutes, 2hours, 6hours and 24 hours after operation
30minutes, 2hours, 6hours and 24 hours after operation
Visual Analogue Scale (VAS) pain score in PACU
Time Frame: 30 minutes after operation
30 minutes after operation
Change of concentration of serum 5-HT
Time Frame: intraoperative
intraoperative
Change of concentration of serum dopamine
Time Frame: intraoperative
intraoperative

Collaborators and Investigators

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

Sponsor

wangqiang

Investigators

  • Study Chair: Lizhe Xiong, M.D.;Ph D, Air Force Military Medical University, China

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

December 1, 2015

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

November 3, 2015

First Submitted That Met QC Criteria

November 4, 2015

First Posted (Estimate)

November 5, 2015

Study Record Updates

Last Update Posted (Estimate)

November 5, 2015

Last Update Submitted That Met QC Criteria

November 4, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • xijingmazui79

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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