<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/NCT03762538</url>
  </required_header>
  <id_info>
    <org_study_id>EAGLES</org_study_id>
    <nct_id>NCT03762538</nct_id>
  </id_info>
  <brief_title>The Effect of the ALDH2 Gene Polymorphism on the Propofol Potency for Inducing Loss of Consciousness</brief_title>
  <official_title>The Effect of the ALDH2 Gene Polymorphism on the Propofol Potency for Inducing Loss of Consciousness in Cardiac Patients: a Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Zhongshan Hospital</source>
  <oversight_info>
    <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 this study is to determine whether ALDH2 gene polymorphisms (G/G, G/A A/A) have&#xD;
      effect on the potency of propofol.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Effect-site concentration</measure>
    <time_frame>immediately after patient lose his/her consciousness</time_frame>
    <description>patient's effect-site concentration when he/she loss consciousness</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Propofol</condition>
  <arm_group>
    <arm_group_label>G/G group</arm_group_label>
    <description>Patients who are determined to be G/G genotype.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>G/A A/A group</arm_group_label>
    <description>Patients who are determined to be G/A or A/A genotypes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>Patients will be induced to unconsciousness using propofol intravenously.</description>
    <arm_group_label>G/A A/A group</arm_group_label>
    <arm_group_label>G/G group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        operation rooms for cardiac surgeries in our institution（a major hospital in China)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA II&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA III-IV&#xD;
&#xD;
          -  OSAS&#xD;
&#xD;
          -  hepatic and renal insufficiency&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Kefang Guo, MD</last_name>
    <phone>+86-13817706936</phone>
    <email>drguokefang@foxmail.com</email>
  </overall_contact>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>November 30, 2018</last_update_submitted>
  <last_update_submitted_qc>November 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>propofol</keyword>
  <keyword>ALDH2</keyword>
  <keyword>potency</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Unconsciousness</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propofol</mesh_term>
  </intervention_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/NCT03762538
org study id: EAGLES
nct id: NCT03762538
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to determine whether ALDH2 gene polymorphisms (G/G, G/A A/A) have
      effect on the potency of propofol.
observational model: Case-Only
time perspective: Prospective
measure: Effect-site concentration
time frame: immediately after patient lose his/her consciousness
description: patient's effect-site concentration when he/she loss consciousness
arm group label: G/G group
description: Patients who are determined to be G/G genotype.
arm group label: G/A A/A group
description: Patients who are determined to be G/A or A/A genotypes.
intervention type: Drug
intervention name: Propofol
description: Patients will be induced to unconsciousness using propofol intravenously.
arm group label: G/A A/A group
arm group label: G/G group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 50 Years
maximum age: 75 Years
healthy volunteers: No
last name: Kefang Guo, MD
phone: +86-13817706936
email: drguokefang@foxmail.com
responsible party type: Sponsor
mesh term: Unconsciousness
mesh term: Propofol