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

Primary Purpose

Postoperative Nausea and Vomiting

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

TEAS (transcutaneous electrical acupoint stimulation)

About this trial

This is an interventional treatment trial for Postoperative Nausea and Vomiting focused on measuring Postoperative nausea and vomiting, TEAS

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

ASA I-III
Aged 18 to 65 years old
Scheduled for general anesthesia
BMI index is between 18 to 30
Informed consented

Exclusion Criteria:

ASA IV
Hypertension that is not controlled
Severe hepatic or renal dysfunction
Ever had received electrical stimulation treatment
Severe systemic infection
With contraindications to the use of TEAS, such as skin damage or infection at the acupoints
For any reason one can not cope with the studies, such as the following:
language comprehension, mental illness
Participate in the other clinical trial 3 month before the enrollment

Sites / Locations

Xijing Hospital, Fourth Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Arm Label

shuangxuezu

neiguanxuezu

zusanlixuezu

duizhaozu

Arm Description

Patients were given 30min of TEAS before induction until the end of the operation at two acupoints.

Patients were given TEAS at neiguan acupoint.

Patients were given TEAS at Zusanli acupoint.

Patients were not given TEAS at two acupoints.

Outcomes

Primary Outcome Measures

The incidence of postoperative nausea and vomiting

Secondary Outcome Measures

Incidence of other postoperative complications

Postoperative nausea and vomiting（PONV） score

Visual Analogue Scale (VAS) pain score in PACU

Change of concentration of serum 5-HT

Change of concentration of serum dopamine

Full Information

NCT ID

NCT02597842

First Posted

November 3, 2015

Last Updated

November 4, 2015

Sponsor

wangqiang

1. Study Identification

Unique Protocol Identification Number

NCT02597842

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Unknown status

Study Start Date

December 2015 (undefined)

Primary Completion Date

August 2016 (Anticipated)

Study Completion Date

October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

wangqiang

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

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, TEAS

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

shuangxuezu

Arm Type

Experimental

Arm Description

Patients were given 30min of TEAS before induction until the end of the operation at two acupoints.

Arm Title

neiguanxuezu

Arm Type

Experimental

Arm Description

Patients were given TEAS at neiguan acupoint.

Arm Title

zusanlixuezu

Arm Type

Experimental

Arm Description

Patients were given TEAS at Zusanli acupoint.

Arm Title

duizhaozu

Arm Type

Sham Comparator

Arm Description

Patients were not given TEAS at two acupoints.

Intervention Type

Device

Intervention Name(s)

TEAS (transcutaneous electrical acupoint stimulation)

Intervention Description

Electric stimulation was given through electrode attached to specific acupoints

Primary Outcome Measure Information:

Title

The incidence of postoperative nausea and vomiting

Time Frame

within 24 hours after operation

Secondary Outcome Measure Information:

Title

Incidence of other postoperative complications

Time Frame

30minutes, 2hours, 6hours and 24 hours after operation

Title

Postoperative nausea and vomiting（PONV） score

Time Frame

30minutes, 2hours, 6hours and 24 hours after operation

Title

Visual Analogue Scale (VAS) pain score in PACU

Time Frame

30 minutes after operation

Title

Change of concentration of serum 5-HT

Time Frame

intraoperative

Title

Change of concentration of serum dopamine

Time Frame

intraoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ASA I-III Aged 18 to 65 years old Scheduled for general anesthesia BMI index is between 18 to 30 Informed consented Exclusion Criteria: ASA IV Hypertension that is not controlled Severe hepatic or renal dysfunction Ever had received electrical stimulation treatment Severe systemic infection With contraindications to the use of TEAS, such as skin damage or infection at the acupoints For any reason one can not cope with the studies, such as the following: language comprehension, mental illness Participate in the other clinical trial 3 month before the enrollment

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Haifeng Duan

Phone

15091626182

875939063@qq.com

First Name & Middle Initial & Last Name or Official Title & Degree

Zhihong Lu, M.D.;Ph D

Phone

029-84775343

deerlu@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lizhe Xiong, M.D.;Ph D

Organizational Affiliation

Air Force Military Medical University, China

Official's Role

Study Chair

Facility Information:

Facility Name

Xijing Hospital, Fourth Military Medical University

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710032

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hailong Dong, M.D., Ph.D.

Phone

86-29-84775337

hldong6@hotmail.com

First Name & Middle Initial & Last Name & Degree

Lize Xiong, M.D., Ph.D.

Phone

+86-29-84775337

lize.xiong@hotmail.com

First Name & Middle Initial & Last Name & Degree

Lize Xiong, M.D., Ph.D.

First Name & Middle Initial & Last Name & Degree

Qiang Wang, M.D., Ph.D.

First Name & Middle Initial & Last Name & Degree

Zhihong Lu, M.D., Ph.D.

First Name & Middle Initial & Last Name & Degree

Haifeng Duan

First Name & Middle Initial & Last Name & Degree

Tingting Liu

12. IPD Sharing Statement

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

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