<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02193477</url>
  </required_header>
  <id_info>
    <org_study_id>Gjian</org_study_id>
    <nct_id>NCT02193477</nct_id>
  </id_info>
  <brief_title>Effect of TEAS on the Incidence Rate of SIRS in Patients Undergoing Abdominal Surgery</brief_title>
  <official_title>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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Air Force Military Medical University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Air Force Military Medical University, China</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to access the effect of Transcutaneous Electrical Acupoint&#xD;
      Stimulation(TEAS) on the Incidence rate of Systemic Inflammatory Response Syndrome (SIRS) in&#xD;
      patients undergoing radical surgery for gastric cancer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients undergoing elective radical surgery for gastric cancer under general anesthesia were&#xD;
      randomly assigned to three groups, control group , TEAS group and sham TEAS group.&#xD;
&#xD;
      TEAS group receiving TEAS before general anesthesia induction , 1th day and 2nd day after&#xD;
      surgery. TEAS was given through electrodes attached to specific acupoints. The time for TEAS&#xD;
      was 30min.&#xD;
&#xD;
      Sham TEAS group receiving sham TEAS before general anesthesia induction , 1th day and 2nd day&#xD;
      after surgery. Sham TEAS was given through electrodes attached to non-acupoints. The time for&#xD;
      sham TEAS was also 30min.&#xD;
&#xD;
      Control group were given no TEAS. Incidence rates of SIRS in each group were compared .Venous&#xD;
      blood samples from all groups(control group , TEAS group and sham TEAS group) were collected&#xD;
      before general anesthesia induction,1th day and 3rd day after surgery. Inflammatory cytokines&#xD;
      index including interleukin-6,interleukin-10,Tumor Necrosis Factor-&#xD;
      alpha(TNF-α),Interferon-γ(IFN-γ),Monocyte Chemotactic Protein 1(MCP-1),IgG,IgM were measured.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence rate of SIRS</measure>
    <time_frame>1st day after surgery</time_frame>
    <description>SIRS is defined as 2 or more of the following variables :&#xD;
Fever of more than 38°C (100.4°F) or less than 36°C (96.8°F)&#xD;
Heart rate of more than 90 beats per minute&#xD;
Respiratory rate of more than 20 breaths per minute or arterial carbon dioxide tension (PaCO2) of less than 32mm Hg&#xD;
Abnormal white blood cell count (&gt;12,000/µL or &lt; 4,000/µL or &gt;10% immature granulocyte forms)&#xD;
Incidence rate of SIRS is calculated using the following formula:&#xD;
(Number of SIRS Cases within the group) / (Number of Cases within the group)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of Inflammatory cytokines</measure>
    <time_frame>30 minutes before general anesthesia induction and 1st and 3rd day after the surgery</time_frame>
    <description>Venous blood samples were collected before general anesthesia induction,1th day and 3rd day after surgery. Inflammatory cytokines index including interleukin-6,interleukin-10,TNF-α,Interferon-γ(IFN-γ),Monocyte Chemotactic Protein 1(MCP-1),IgG,IgM were measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence rate of SIRS</measure>
    <time_frame>3rd day after surgery</time_frame>
    <description>SIRS is defined as 2 or more of the following variables :&#xD;
Fever of more than 38°C (100.4°F) or less than 36°C (96.8°F) Heart rate of more than 90 beats per minute Respiratory rate of more than 20 breaths per minute or arterial carbon dioxide tension (PaCO2) of less than 32mm Hg Abnormal white blood cell count (&gt;12,000/µL or &lt; 4,000/µL or &gt;10% immature granulocyte forms)&#xD;
Incidence rate of SIRS is calculated using the following formula:&#xD;
(Number of SIRS Cases within the group) / (Number of Cases within the group)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>Systemic Inflammatory Response Syndrome</condition>
  <condition>Inflammation</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients were given no TEAS.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TEAS Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients were given 30min of TEAS before general anesthesia induction, 1th day and 2nd day after surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham TEAS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients were given 30min of sham TEAS before general anesthesia induction,1th day and 2nd day after surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TEAS</intervention_name>
    <description>Electric stimulation was given through electrode attached to specific acupoints for 30mins before general anesthesia induction,1th day and 2nd day after surgery.</description>
    <arm_group_label>TEAS Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham TEAS</intervention_name>
    <description>Electric stimulation was given through electrode attached to non-acupoints for 30mins before general anesthesia induction,1th day and 2nd day after surgery.</description>
    <arm_group_label>Sham TEAS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age&gt;30yrs,&lt;75yrs&#xD;
&#xD;
          -  ASA 1-2&#xD;
&#xD;
          -  Scheduled for radical surgery for gastric cancer under general anesthesia；&#xD;
&#xD;
          -  Informed consented&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with implanted pacemakers&#xD;
&#xD;
          -  Patients with severe hypertension or cardiac dysfunction；&#xD;
&#xD;
          -  Patients with severe pulmonary disease&#xD;
&#xD;
          -  Patients with hemoglobin&lt;90g/L&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Qiang Wang, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Air Force Military Medical University, China</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fourth Military Medical University</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>July 6, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>March 5, 2015</last_update_submitted>
  <last_update_submitted_qc>March 5, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 6, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Air Force Military Medical University, China</investigator_affiliation>
    <investigator_full_name>QiangWang,MD</investigator_full_name>
    <investigator_title>associate professor,PhD advisor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Inflammation</mesh_term>
    <mesh_term>Systemic Inflammatory Response Syndrome</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02193477
org study id: Gjian
nct id: NCT02193477
lead sponsor: 
has dmc: No
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
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Incidence rate of SIRS
time frame: 1st day after surgery
description: SIRS is defined as 2 or more of the following variables :
Fever of more than 38°C (100.4°F) or less than 36°C (96.8°F)
Heart rate of more than 90 beats per minute
Respiratory rate of more than 20 breaths per minute or arterial carbon dioxide tension (PaCO2) of less than 32mm Hg
Abnormal white blood cell count (>12,000/µL or < 4,000/µL or >10% immature granulocyte forms)
Incidence rate of SIRS is calculated using the following formula:
(Number of SIRS Cases within the group) / (Number of Cases within the group)
measure: Change of Inflammatory cytokines
time frame: 30 minutes before general anesthesia induction and 1st and 3rd day after the surgery
description: Venous blood samples were collected before general anesthesia induction,1th day and 3rd day after surgery. Inflammatory cytokines index including interleukin-6,interleukin-10,TNF-α,Interferon-γ(IFN-γ),Monocyte Chemotactic Protein 1(MCP-1),IgG,IgM were measured.
measure: Incidence rate of SIRS
time frame: 3rd day after surgery
description: SIRS is defined as 2 or more of the following variables :
Fever of more than 38°C (100.4°F) or less than 36°C (96.8°F) Heart rate of more than 90 beats per minute Respiratory rate of more than 20 breaths per minute or arterial carbon dioxide tension (PaCO2) of less than 32mm Hg Abnormal white blood cell count (>12,000/µL or < 4,000/µL or >10% immature granulocyte forms)
Incidence rate of SIRS is calculated using the following formula:
(Number of SIRS Cases within the group) / (Number of Cases within the group)
arm group label: Control
arm group type: No Intervention
description: Patients were given no TEAS.
arm group label: TEAS Treatment
arm group type: Experimental
description: Patients were given 30min of TEAS before general anesthesia induction, 1th day and 2nd day after surgery.
arm group label: Sham TEAS
arm group type: Sham Comparator
description: Patients were given 30min of sham TEAS before general anesthesia induction,1th day and 2nd day after surgery.
intervention type: Device
intervention name: TEAS
description: Electric stimulation was given through electrode attached to specific acupoints for 30mins before general anesthesia induction,1th day and 2nd day after surgery.
arm group label: TEAS Treatment
intervention type: Device
intervention name: Sham TEAS
description: Electric stimulation was given through electrode attached to non-acupoints for 30mins before general anesthesia induction,1th day and 2nd day after surgery.
arm group label: Sham TEAS
criteria: 
gender: All
minimum age: 30 Years
maximum age: 75 Years
healthy volunteers: No
last name: Qiang Wang, MD
role: Study Chair
affiliation: Air Force Military Medical University, China
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Air Force Military Medical University, China
investigator full name: QiangWang,MD
investigator title: associate professor,PhD advisor
mesh term: Syndrome
mesh term: Inflammation
mesh term: Systemic Inflammatory Response Syndrome