<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/NCT03821428</url>
  </required_header>
  <id_info>
    <org_study_id>BB 166/18</org_study_id>
    <nct_id>NCT03821428</nct_id>
  </id_info>
  <brief_title>Acupuncture for Relief of Gag Reflex</brief_title>
  <acronym>AcuGag</acronym>
  <official_title>Acupuncture for Relief of Gag Reflex in Patients Undergoing Transesophageal Echocardiography - a Randomized Placebo-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medicine Greifswald</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Medicine Greifswald</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to test whether stimulation of acupuncture points CV24 and P6 is&#xD;
      better than placebo acupuncture in treatment of gagging in patients undergoing elective&#xD;
      transesophageal echocardiography (TEE)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients undergoing elective transesophageal echocardiography (TEE) often report discomfort&#xD;
      because of active gagging reflex, which sometimes preclude the performance of TEE and&#xD;
      requires additional medication. According to existing literature, needling of acupoint CV24&#xD;
      effectively prevents gagging during dental procedures. We are going to use this phenomenon in&#xD;
      patients scheduled to TEE in order to reduce discomfort during insertion of TEE probe and&#xD;
      reduce the need for additional sedative medication. Within this investigation the patients&#xD;
      will be randomly assigned to receive either verum acupuncture of CV24 and P6 acupoints or&#xD;
      placebo procedure immediately before TEE examination. As outcome the incidence and intensity&#xD;
      of gagging, total dose of additional sedative medication and hemodynamic parameters will be&#xD;
      recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 13, 2019</start_date>
  <completion_date type="Anticipated">May 20, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 20, 2021</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of gagging during probe insertion</measure>
    <time_frame>10 minutes after TEE probe insertion</time_frame>
    <description>Incidence of gagging during TEE probe insertion: yes=1; no=2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gagging score</measure>
    <time_frame>10 minutes after TEE probe insertion</time_frame>
    <description>Gagging score on Verbal Rating Scale from 0 to 10, where 0=no discomfort from TEE probe; 10=maximal discomfort during TEE probe insertion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rescue medication</measure>
    <time_frame>10 minutes after TEE probe insertion</time_frame>
    <description>Use of midazolam as rescue medication, given as a summary dose of required midazolam from minimum 1 milligram to maximum 10 milligram</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Gagging During Transesophageal Echocardiography</condition>
  <arm_group>
    <arm_group_label>Acupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Needling of acupoints P6 and CV24 with indwelling permanent needles, withdrawn after TEE procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Application of Placebo needles in the areas of P6 and CV24 acupoints</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Acupuncture</intervention_name>
    <description>Needling of P6 and CV24 points</description>
    <arm_group_label>Acupuncture</arm_group_label>
    <other_name>Verum acupuncture</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Application of placebo acupuncture needles to the areas, where the acupoints are situated</description>
    <arm_group_label>Control</arm_group_label>
    <other_name>Placebo acupuncture</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with an American Society of Anesthesiologists physical status of I to III&#xD;
             scheduled for elective ambulatory transesophageal echocardiography (TEE) without&#xD;
             sedation&#xD;
&#xD;
          2. TEE time does not exceed 30 minutes&#xD;
&#xD;
          3. Patients without previous opioid and psychotropic medication&#xD;
&#xD;
          4. Patients aged between 30 and 65 years, able to use visual analogue scale 100 mm&#xD;
&#xD;
          5. Patients who have given written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current psychiatric disease&#xD;
&#xD;
          2. Local skin infection at the sites of acupuncture&#xD;
&#xD;
          3. Aged &lt; 30 or &gt; 65 years&#xD;
&#xD;
          4. TEE time more than 30 min&#xD;
&#xD;
          5. Patients who consumed opioid medication at least 6 months before surgery&#xD;
&#xD;
          6. Patients with the history of: i) psychiatric disease; ii) insulin-dependent diabetes&#xD;
             mellitus; iii) radio- or chemotherapy; iv) peripheral polyneuropathy.&#xD;
&#xD;
          7. Patients who are unable to understand the consent form or to use visual analogue scale&#xD;
             100 mm&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Taras Usichenko</last_name>
    <role>Study Chair</role>
    <affiliation>University Medicine of Greifswald</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Taras Usichenko, MD, PhD</last_name>
    <phone>+49 3834865893</phone>
    <email>taras@uni-greifswald.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Irina Müller-Kozarez, MD</last_name>
    <phone>+49 38348680699</phone>
    <email>irina.mueller-kozarez@uni-greifswald.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Medicine of Greifswald</name>
      <address>
        <city>Greifswald</city>
        <zip>17475</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Irina Müller-Kozarez, MD, PhD</last_name>
      <phone>+4938348680699</phone>
      <email>irina.mueller-kozarez@uni-greifswald.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>January 8, 2021</last_update_submitted>
  <last_update_submitted_qc>January 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2021</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>Gagging</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/NCT03821428
org study id: BB 166/18
nct id: NCT03821428
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to test whether stimulation of acupuncture points CV24 and P6 is
      better than placebo acupuncture in treatment of gagging in patients undergoing elective
      transesophageal echocardiography (TEE)
Patients undergoing elective transesophageal echocardiography (TEE) often report discomfort
      because of active gagging reflex, which sometimes preclude the performance of TEE and
      requires additional medication. According to existing literature, needling of acupoint CV24
      effectively prevents gagging during dental procedures. We are going to use this phenomenon in
      patients scheduled to TEE in order to reduce discomfort during insertion of TEE probe and
      reduce the need for additional sedative medication. Within this investigation the patients
      will be randomly assigned to receive either verum acupuncture of CV24 and P6 acupoints or
      placebo procedure immediately before TEE examination. As outcome the incidence and intensity
      of gagging, total dose of additional sedative medication and hemodynamic parameters will be
      recorded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Incidence of gagging during probe insertion
time frame: 10 minutes after TEE probe insertion
description: Incidence of gagging during TEE probe insertion: yes=1; no=2
measure: Gagging score
time frame: 10 minutes after TEE probe insertion
description: Gagging score on Verbal Rating Scale from 0 to 10, where 0=no discomfort from TEE probe; 10=maximal discomfort during TEE probe insertion
measure: Rescue medication
time frame: 10 minutes after TEE probe insertion
description: Use of midazolam as rescue medication, given as a summary dose of required midazolam from minimum 1 milligram to maximum 10 milligram
arm group label: Acupuncture
arm group type: Experimental
description: Needling of acupoints P6 and CV24 with indwelling permanent needles, withdrawn after TEE procedure
arm group label: Control
arm group type: Placebo Comparator
description: Application of Placebo needles in the areas of P6 and CV24 acupoints
intervention type: Procedure
intervention name: Acupuncture
description: Needling of P6 and CV24 points
arm group label: Acupuncture
other name: Verum acupuncture
intervention type: Procedure
intervention name: Placebo
description: Application of placebo acupuncture needles to the areas, where the acupoints are situated
arm group label: Control
other name: Placebo acupuncture
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: No
last name: Taras Usichenko
role: Study Chair
affiliation: University Medicine of Greifswald
last name: Taras Usichenko, MD, PhD
phone: +49 3834865893
email: taras@uni-greifswald.de
last name: Irina Müller-Kozarez, MD
phone: +49 38348680699
email: irina.mueller-kozarez@uni-greifswald.de
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Sponsor
mesh term: Gagging
sharing ipd: No