<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/NCT02239159</url>
  </required_header>
  <id_info>
    <org_study_id>XJH-A-2014-02-21-1</org_study_id>
    <nct_id>NCT02239159</nct_id>
  </id_info>
  <brief_title>Acupuncture-assisted-anesthesia to Improve Postoperative Outcome After Digestive Surgery in Elderly Patients</brief_title>
  <acronym>AID</acronym>
  <official_title>Acupuncture-assisted-anesthesia to Improve Complications After Digestive Surgery in Elderly Patients:Multi-center Double-blinded Randomized Controlled Trial</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators assume that transcutaneous electric acupoint stimulation (TEAS)&#xD;
      pretreatment may activate the endogenous protective mechanism, as a result protect the&#xD;
      patients against subsequent surgical stress pregnancy. And TEAS may induce the production of&#xD;
      endogenous analgesic transmitters, so develop an anesthetic-sparing effect. The investigators&#xD;
      believe this intervention will reduce the subsequent incidence, duration and severity of&#xD;
      organ dysfunction, possibly reducing the morbidity, even mortality. So in this study, the&#xD;
      investigators hypothesize that TEAS before anesthesia and during surgery would decrease the&#xD;
      morbidity and mortality of postoperative complications in 30 days after digestive surgery in&#xD;
      elderly patients .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients older than 65 years old are at higher risk of postoperative morbidity and mortality.&#xD;
      With the increasing number of old patients scheduled for digestive surgery, exploring methods&#xD;
      to decrease postoperative morbidity is very important. Noninvasive methods may be easier to&#xD;
      clinically use. Transcutaneous electric acupoint stimulation (TEAS)has been proved to&#xD;
      decrease need for general anesthetics during anesthesia, and to alleviate systemic&#xD;
      inflammatory response. Considering the morbidity and mortality after surgery is closely&#xD;
      related to use of anesthetics and inflammatory response,TEAS may be a good selection for&#xD;
      improving postoperative outcomes.Among the postoperative complications, pulmonary&#xD;
      complication and systemic inflammatory response syndrome is with higher incidence, so we will&#xD;
      focus on these two complications in our study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with Pulmonary Adverse Events as a Measure of Morbidity Tolerability</measure>
    <time_frame>participants will be followed from the end of the surgery to 30 days after surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants died of all causes</measure>
    <time_frame>Participants will be followed from the end of the surgery to 30 days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of ICU stay</measure>
    <time_frame>participants will be followed for the duration of hospital stay after surgery, an expected average of 7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with ICU admission</measure>
    <time_frame>participants will be followed for the duration of hospital stay after surgery, an expected average of 7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Systemic Inflammatory Response Syndrome(SIRS)</measure>
    <time_frame>Participants will be followed from the end of the surgery to 30 days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>participants will be followed for the duration of hospital stay after surgery, an expected average of 7days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">748</enrollment>
  <condition>Postoperative Complications</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Electrodes will be attached, but stimulation will not be given</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-acupoint TES</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>TES is for transcutaneous electric stimulation.Stimulation will be given through electrodes attached to non-acupoints</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acupoint TES</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transcutaneous stimulation will be given through acupoints</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>TES(transcutaneous electric stimulation)</intervention_name>
    <description>Stimulation will be given through electrodes attached to the skin</description>
    <arm_group_label>Acupoint TES</arm_group_label>
    <arm_group_label>Non-acupoint TES</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provide written informed consent&#xD;
&#xD;
          -  Age ≥65 years of age&#xD;
&#xD;
          -  Elective digestive surgery under general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA(American Society of Anesthesiologists) status&gt; Ⅲ&#xD;
&#xD;
          -  Patients undergoing surgery within 12 h of admission to hospital&#xD;
&#xD;
          -  Patients undergoing surgery of the chest&#xD;
&#xD;
          -  Patients suffered from neurologic disorder or impaired mental state&#xD;
&#xD;
          -  Patients with contraindications to the use of electro-acupuncture, such as skin damage&#xD;
             or infection at the acupoints&#xD;
&#xD;
          -  Patients with experience of transcutaneous electrical stimulation treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lize Xiong, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Air Force Military Medical University, China</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Xijing Hospital,Fourth Military Medical University</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>April 6, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>July 6, 2017</last_update_submitted>
  <last_update_submitted_qc>July 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2017</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>Zhihong LU</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>transcutaneous electric acupoint stimulation</keyword>
  <keyword>elderly patients</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Complications</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/NCT02239159
org study id: XJH-A-2014-02-21-1
nct id: NCT02239159
lead sponsor: 
has dmc: Yes
The investigators assume that transcutaneous electric acupoint stimulation (TEAS)
      pretreatment may activate the endogenous protective mechanism, as a result protect the
      patients against subsequent surgical stress pregnancy. And TEAS may induce the production of
      endogenous analgesic transmitters, so develop an anesthetic-sparing effect. The investigators
      believe this intervention will reduce the subsequent incidence, duration and severity of
      organ dysfunction, possibly reducing the morbidity, even mortality. So in this study, the
      investigators hypothesize that TEAS before anesthesia and during surgery would decrease the
      morbidity and mortality of postoperative complications in 30 days after digestive surgery in
      elderly patients .
Patients older than 65 years old are at higher risk of postoperative morbidity and mortality.
      With the increasing number of old patients scheduled for digestive surgery, exploring methods
      to decrease postoperative morbidity is very important. Noninvasive methods may be easier to
      clinically use. Transcutaneous electric acupoint stimulation (TEAS)has been proved to
      decrease need for general anesthetics during anesthesia, and to alleviate systemic
      inflammatory response. Considering the morbidity and mortality after surgery is closely
      related to use of anesthetics and inflammatory response,TEAS may be a good selection for
      improving postoperative outcomes.Among the postoperative complications, pulmonary
      complication and systemic inflammatory response syndrome is with higher incidence, so we will
      focus on these two complications in our study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Number of Participants with Pulmonary Adverse Events as a Measure of Morbidity Tolerability
time frame: participants will be followed from the end of the surgery to 30 days after surgery
measure: Number of participants died of all causes
time frame: Participants will be followed from the end of the surgery to 30 days after surgery
measure: Length of ICU stay
time frame: participants will be followed for the duration of hospital stay after surgery, an expected average of 7 days
measure: Number of participants with ICU admission
time frame: participants will be followed for the duration of hospital stay after surgery, an expected average of 7 days
measure: Number of participants with Systemic Inflammatory Response Syndrome(SIRS)
time frame: Participants will be followed from the end of the surgery to 30 days after surgery
measure: Length of hospital stay
time frame: participants will be followed for the duration of hospital stay after surgery, an expected average of 7days
arm group label: Control
arm group type: No Intervention
description: Electrodes will be attached, but stimulation will not be given
arm group label: Non-acupoint TES
arm group type: Sham Comparator
description: TES is for transcutaneous electric stimulation.Stimulation will be given through electrodes attached to non-acupoints
arm group label: Acupoint TES
arm group type: Experimental
description: Transcutaneous stimulation will be given through acupoints
intervention type: Other
intervention name: TES(transcutaneous electric stimulation)
description: Stimulation will be given through electrodes attached to the skin
arm group label: Acupoint TES
arm group label: Non-acupoint TES
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Lize Xiong, PhD
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: Zhihong LU
investigator title: Dr.
mesh term: Postoperative Complications