<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/NCT03775122</url>
  </required_header>
  <id_info>
    <org_study_id>renji-2018-074</org_study_id>
    <nct_id>NCT03775122</nct_id>
  </id_info>
  <brief_title>TAES Improve the Function of Respiration and Circulation on Elderly Patients Undergoing Colonoscopy Procedure</brief_title>
  <official_title>Transcutaneous Acupoint Electrical Stimulation Improve the Function of Respiration and Circulation on Elderly Patients Undergoing Colonoscopy Procedure：A Randomized-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RenJi Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To explore the effectiveness of transcutaneous acupuncture electrical stimulation (TAES), a&#xD;
      non-invasive modality in improvement of the function of respiration and circulation on elder&#xD;
      patient during colonoscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To assess the function of respiratory and circulation before precondition, during colonoscopy&#xD;
      and end of the procedure, blood cortisol and catecholamine levels were measured also.The&#xD;
      incidence of airway support, application of vasoactive drug or atropine during procedure were&#xD;
      recorded in the meantime.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">February 15, 2019</start_date>
  <completion_date type="Anticipated">April 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2019</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The percentage of oxygen saturation</measure>
    <time_frame>from 20min before lay down to 24hours after performance</time_frame>
    <description>The percentage of oxygen saturation between the sedation alone and sedation+TAES have at least 2 difference</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Respiratory Depression</condition>
  <arm_group>
    <arm_group_label>Group 1 sedation group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Elderly patients under colonoscopy with sedation, but no real TAES neiguan(pc6)&#xD;
sedation is using the typical protocol for the following: Slowly peripheral intravenous injection(0.5ml/s) of fentanyl 50μg, then followed with 1.5-2.5mg/kg propofol until loss of eyelash reflex, the Observer's Assessment of Alertness/Sedation Scale (OAAS) score Level3-5.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 sedation+TAES group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Elderly patients under colonoscopy both have TAES neiguan(pc6) and sedation.&#xD;
sedation is begun followed TAES. sedation is same as group2 do. TAES is same as group3 do.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TAES</intervention_name>
    <description>TAES over acupuncture point neiguan (pericardium 6) for 20min, placebo group only stick the stimulate electrode but no frequency and intensity</description>
    <arm_group_label>Group 1 sedation group</arm_group_label>
    <arm_group_label>Group 2 sedation+TAES group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. patients aged 65 or older&#xD;
&#xD;
          2. American Society of Anesthesiologists (ASA) grade I~II&#xD;
&#xD;
          3. consent and voluntary participation in this experiment&#xD;
&#xD;
          4. patients under colonoscopy&#xD;
&#xD;
          5. none allergic to propofol and fentanyl&#xD;
&#xD;
          6. airway assessment for none difficult airway&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Allergic to propofol, fentanyl.&#xD;
&#xD;
          2. ASA is greater than or equal to grade 3&#xD;
&#xD;
          3. Abnormal respiratory tract may cause severe respiratory obstruction&#xD;
&#xD;
          4. unsatisfactory control of hypertension, systolic pressure over 160 millimeter of&#xD;
             mercury (mmHg) or diastolic pressure over 100 mmHg&#xD;
&#xD;
          5. Hypotension, systolic pressure below 90 mmHg, heart rate (HR) &lt;50bpm or &gt;100bpm&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yu Weifeng, Dr</last_name>
    <role>Study Director</role>
    <affiliation>Renji Hospital,School of Medicine,Shanghai Jiaotong University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>chen yongming</last_name>
    <phone>13564932181</phone>
    <email>drchelman@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lu Qi</last_name>
    <phone>86(21)68383364</phone>
    <email>rjllb3364@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Diansan Su</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200127</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>diansan su, Dr.</last_name>
      <phone>+862168383702</phone>
      <email>diansansu@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>February 15, 2019</last_update_submitted>
  <last_update_submitted_qc>February 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03775122
org study id: renji-2018-074
nct id: NCT03775122
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
To explore the effectiveness of transcutaneous acupuncture electrical stimulation (TAES), a
      non-invasive modality in improvement of the function of respiration and circulation on elder
      patient during colonoscopy.
To assess the function of respiratory and circulation before precondition, during colonoscopy
      and end of the procedure, blood cortisol and catecholamine levels were measured also.The
      incidence of airway support, application of vasoactive drug or atropine during procedure were
      recorded in the meantime.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: The percentage of oxygen saturation
time frame: from 20min before lay down to 24hours after performance
description: The percentage of oxygen saturation between the sedation alone and sedation+TAES have at least 2 difference
arm group label: Group 1 sedation group
arm group type: Placebo Comparator
description: Elderly patients under colonoscopy with sedation, but no real TAES neiguan(pc6)
sedation is using the typical protocol for the following: Slowly peripheral intravenous injection(0.5ml/s) of fentanyl 50μg, then followed with 1.5-2.5mg/kg propofol until loss of eyelash reflex, the Observer's Assessment of Alertness/Sedation Scale (OAAS) score Level3-5.
arm group label: Group 2 sedation+TAES group
arm group type: Experimental
description: Elderly patients under colonoscopy both have TAES neiguan(pc6) and sedation.
sedation is begun followed TAES. sedation is same as group2 do. TAES is same as group3 do.
intervention type: Device
intervention name: TAES
description: TAES over acupuncture point neiguan (pericardium 6) for 20min, placebo group only stick the stimulate electrode but no frequency and intensity
arm group label: Group 1 sedation group
arm group label: Group 2 sedation+TAES group
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Yu Weifeng, Dr
role: Study Director
affiliation: Renji Hospital,School of Medicine,Shanghai Jiaotong University
last name: chen yongming
phone: 13564932181
email: drchelman@hotmail.com
last name: Lu Qi
phone: 86(21)68383364
email: rjllb3364@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Respiratory Insufficiency
sharing ipd: No