<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/NCT01700855</url>
  </required_header>
  <id_info>
    <org_study_id>mazuike-28</org_study_id>
    <nct_id>NCT01700855</nct_id>
  </id_info>
  <brief_title>Electroacupuncture Anesthesia for Nasal Sinus Surgery and Mammaplasty</brief_title>
  <official_title>Electroacupuncture for Pain Relief in Patients With Nasal Sinus Surgery and Mammaplasty: a Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xijing Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xijing Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to verify the intraoperative analgesia of electroacupuncture in&#xD;
      patients undergoing selective nasal sinus surgery and mammaplasty.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acupuncture therapy has been proved helpful in the patients suffering from various pain&#xD;
      problems. And it is reported to be able to reduce the intraoperative anesthetic requirement.&#xD;
      However, so far there is few evidence from randomized controlled studies to confirm the&#xD;
      assistant anesthetic effect of acupuncture. Electroacupuncture (EA) is a modern non-invasive&#xD;
      technique of traditional acupuncture. Compared to traditional acupuncture, EA is more&#xD;
      practicable, more easily to be accepted by patients and operated by physicians. Nasal sinus&#xD;
      surgery and mammaplasty, especially breast augmentation, mostly belong to the scope of day&#xD;
      surgeries, which demand a rapid, smooth recovery from anesthesia with minimum adverse side&#xD;
      effects (e.g.: pain, PONV, etc).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">November 2012</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the mean infusion rate of intraoperative remifentanil and propofol</measure>
    <time_frame>during operation</time_frame>
    <description>To investigate the operative time and total volume of remifentanil and propofol used during operation, and then calculate the mean infusion rate. To assess whether intraoperative requirements for anesthetic drugs could be reduced by EA pretreatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual analogue scale</measure>
    <time_frame>post-operative 4h, 8h, 24h and 48h</time_frame>
    <description>To assess whether EA pretreatment could help in alleviating acute post-operative pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extubation time</measure>
    <time_frame>postoperation</time_frame>
    <description>To investigate the time from the end of propofol and remifentanil infusion to extubation. To assess whether EA pretreatment could shorten the extubation time.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>plasma β-endorphin and cortisol concentration</measure>
    <time_frame>preoperation, 0h and 24h postoperation</time_frame>
    <description>To assess whether EA pretreatment could increase the plasma levels of β-endorphin and cortisol.</description>
  </other_outcome>
  <other_outcome>
    <measure>Ramsay score</measure>
    <time_frame>post-operative 4h, 8h, 24h, 48h</time_frame>
    <description>To assess the effect of EA pretreatment on post-operative Ramsay scores.</description>
  </other_outcome>
  <other_outcome>
    <measure>incidence of post-operative nausea and vomiting (PONV)</measure>
    <time_frame>within post-operative 24 hours</time_frame>
    <description>To assess the effect of EA pretreatment on PONV.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">137</enrollment>
  <condition>Therapeutic (Nonsurgical) and Rehabilitative Anesthesiology Devices Associated With Adverse Incidents</condition>
  <arm_group>
    <arm_group_label>Electroacupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients received electroacupuncture stimulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-electroacupuncture</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients received sham electroacupuncture</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>non-electroacupuncture</intervention_name>
    <description>The same procedure as electroacupuncture except stimulation</description>
    <arm_group_label>Non-electroacupuncture</arm_group_label>
    <other_name>Sham</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Electroacupuncture</intervention_name>
    <description>Electrodes are applied to bilateral &quot;Hegu(L14)&quot; acupoints at the time of 1h before operation, and connected to Hwato Electronic Acupuncture Treatment Instrument (Model No. SDZ-V, Suzhou Medical Appliances Co., Ltd., Suzhou, China). The acupoints are stimulated at an intensity of 3~6 mA and a frequency of 2/30 Hz for 30 min. The highest intensity will be chosen at which the patient can tolerate.</description>
    <arm_group_label>Electroacupuncture</arm_group_label>
    <other_name>Electroacupuncture preconditioning</other_name>
    <other_name>Electroacupuncture pretreatment</other_name>
    <other_name>Transcutaneous electric nerve stimulation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  selective nasal sinus surgery&#xD;
&#xD;
          -  selective mammaplasty&#xD;
&#xD;
          -  patients who accept the follow-up and sign the informed consent&#xD;
&#xD;
          -  ASA 1~2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  emergent surgery&#xD;
&#xD;
          -  pregnant or breast-feeding women&#xD;
&#xD;
          -  coagulopathy&#xD;
&#xD;
          -  history of gastrointestinal ulcer&#xD;
&#xD;
          -  liver or renal dysfunction&#xD;
&#xD;
          -  enrollment in other clinical trials at the same time not reaching the primary endpoint&#xD;
             and probably interference the present trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>29 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Qiang Wang, M.D., Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Xijing Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Xijing Hospital</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>May 2012</verification_date>
  <study_first_submitted>September 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>July 10, 2014</last_update_submitted>
  <last_update_submitted_qc>July 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Xijing Hospital</investigator_affiliation>
    <investigator_full_name>wangqiang</investigator_full_name>
    <investigator_title>Associate Professor, Associate Consultant</investigator_title>
  </responsible_party>
  <keyword>Electroacupuncture</keyword>
  <keyword>Analgesia</keyword>
  <keyword>Anesthesia</keyword>
  <keyword>Nasal septoplasty</keyword>
  <keyword>Mammaplasty</keyword>
  <!-- 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/NCT01700855
org study id: mazuike-28
nct id: NCT01700855
lead sponsor: 
has dmc: Yes
The purpose of this study is to verify the intraoperative analgesia of electroacupuncture in
      patients undergoing selective nasal sinus surgery and mammaplasty.
Acupuncture therapy has been proved helpful in the patients suffering from various pain
      problems. And it is reported to be able to reduce the intraoperative anesthetic requirement.
      However, so far there is few evidence from randomized controlled studies to confirm the
      assistant anesthetic effect of acupuncture. Electroacupuncture (EA) is a modern non-invasive
      technique of traditional acupuncture. Compared to traditional acupuncture, EA is more
      practicable, more easily to be accepted by patients and operated by physicians. Nasal sinus
      surgery and mammaplasty, especially breast augmentation, mostly belong to the scope of day
      surgeries, which demand a rapid, smooth recovery from anesthesia with minimum adverse side
      effects (e.g.: pain, PONV, etc).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
measure: the mean infusion rate of intraoperative remifentanil and propofol
time frame: during operation
description: To investigate the operative time and total volume of remifentanil and propofol used during operation, and then calculate the mean infusion rate. To assess whether intraoperative requirements for anesthetic drugs could be reduced by EA pretreatment.
measure: Visual analogue scale
time frame: post-operative 4h, 8h, 24h and 48h
description: To assess whether EA pretreatment could help in alleviating acute post-operative pain.
measure: Extubation time
time frame: postoperation
description: To investigate the time from the end of propofol and remifentanil infusion to extubation. To assess whether EA pretreatment could shorten the extubation time.
measure: plasma β-endorphin and cortisol concentration
time frame: preoperation, 0h and 24h postoperation
description: To assess whether EA pretreatment could increase the plasma levels of β-endorphin and cortisol.
measure: Ramsay score
time frame: post-operative 4h, 8h, 24h, 48h
description: To assess the effect of EA pretreatment on post-operative Ramsay scores.
measure: incidence of post-operative nausea and vomiting (PONV)
time frame: within post-operative 24 hours
description: To assess the effect of EA pretreatment on PONV.
arm group label: Electroacupuncture
arm group type: Experimental
description: Patients received electroacupuncture stimulation
arm group label: Non-electroacupuncture
arm group type: Sham Comparator
description: Patients received sham electroacupuncture
intervention type: Procedure
intervention name: non-electroacupuncture
description: The same procedure as electroacupuncture except stimulation
arm group label: Non-electroacupuncture
other name: Sham
intervention type: Procedure
intervention name: Electroacupuncture
description: Electrodes are applied to bilateral "Hegu(L14)" acupoints at the time of 1h before operation, and connected to Hwato Electronic Acupuncture Treatment Instrument (Model No. SDZ-V, Suzhou Medical Appliances Co., Ltd., Suzhou, China). The acupoints are stimulated at an intensity of 3~6 mA and a frequency of 2/30 Hz for 30 min. The highest intensity will be chosen at which the patient can tolerate.
arm group label: Electroacupuncture
other name: Electroacupuncture preconditioning
other name: Electroacupuncture pretreatment
other name: Transcutaneous electric nerve stimulation
criteria: 
gender: All
minimum age: 29 Years
maximum age: 60 Years
healthy volunteers: No
last name: Qiang Wang, M.D., Ph.D.
role: Study Director
affiliation: Xijing Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Xijing Hospital
investigator full name: wangqiang
investigator title: Associate Professor, Associate Consultant