Effect of TEAS on the Incidence Rate of SIRS in Patients Undergoing Abdominal Surgery

NCT ID: NCT02193477

Last Updated: 2015-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-01-31

Brief Summary

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The purpose of this study is to access the effect of Transcutaneous Electrical Acupoint Stimulation(TEAS) on the Incidence rate of Systemic Inflammatory Response Syndrome (SIRS) in patients undergoing radical surgery for gastric cancer

Detailed Description

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Patients undergoing elective radical surgery for gastric cancer under general anesthesia were randomly assigned to three groups, control group , TEAS group and sham TEAS group.

TEAS group receiving TEAS before general anesthesia induction , 1th day and 2nd day after surgery. TEAS was given through electrodes attached to specific acupoints. The time for TEAS was 30min.

Sham TEAS group receiving sham TEAS before general anesthesia induction , 1th day and 2nd day after surgery. Sham TEAS was given through electrodes attached to non-acupoints. The time for sham TEAS was also 30min.

Control group were given no TEAS. Incidence rates of SIRS in each group were compared .Venous blood samples from all groups(control group , TEAS group and sham TEAS group) were collected before general anesthesia induction,1th day and 3rd day after surgery. Inflammatory cytokines index including interleukin-6,interleukin-10,Tumor Necrosis Factor- alpha(TNF-α),Interferon-γ(IFN-γ),Monocyte Chemotactic Protein 1(MCP-1),IgG,IgM were measured.

Conditions

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Systemic Inflammatory Response Syndrome Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

Patients were given no TEAS.

Group Type NO_INTERVENTION

No interventions assigned to this group

TEAS Treatment

Patients were given 30min of TEAS before general anesthesia induction, 1th day and 2nd day after surgery.

Group Type EXPERIMENTAL

TEAS

Intervention Type DEVICE

Electric stimulation was given through electrode attached to specific acupoints for 30mins before general anesthesia induction,1th day and 2nd day after surgery.

Sham TEAS

Patients were given 30min of sham TEAS before general anesthesia induction,1th day and 2nd day after surgery.

Group Type SHAM_COMPARATOR

Sham TEAS

Intervention Type DEVICE

Electric stimulation was given through electrode attached to non-acupoints for 30mins before general anesthesia induction,1th day and 2nd day after surgery.

Interventions

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TEAS

Electric stimulation was given through electrode attached to specific acupoints for 30mins before general anesthesia induction,1th day and 2nd day after surgery.

Intervention Type DEVICE

Sham TEAS

Electric stimulation was given through electrode attached to non-acupoints for 30mins before general anesthesia induction,1th day and 2nd day after surgery.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age\>30yrs,\<75yrs
* ASA 1-2
* Scheduled for radical surgery for gastric cancer under general anesthesia;
* Informed consented

Exclusion Criteria

* Patients with implanted pacemakers
* Patients with severe hypertension or cardiac dysfunction;
* Patients with severe pulmonary disease
* Patients with hemoglobin\<90g/L
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Air Force Military Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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QiangWang,MD

associate professor,PhD advisor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qiang Wang, MD

Role: STUDY_CHAIR

Air Force Military Medical University, China

Locations

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Fourth Military Medical University

Xi’an, Shanxi, China

Site Status

Countries

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China

Other Identifiers

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Gjian

Identifier Type: -

Identifier Source: org_study_id

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