<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/NCT03839186</url>
  </required_header>
  <id_info>
    <org_study_id>XYHMZK PG 2000</org_study_id>
    <nct_id>NCT03839186</nct_id>
  </id_info>
  <brief_title>Pharmacogenetics Study on the Effects of Anesthetic Drugs on Circulatory Function</brief_title>
  <official_title>The Effects of Anesthetic Drugs on Hemodynamic Changes in Cardiac Surgury and the Assotiation Between Gene Polymorphysim and Different Heart Diseases :a Pharmacogenetics Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xiangya Hospital of Central South University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xiangya Hospital of Central South University</source>
  <brief_summary>
    <textblock>
      This study intends to study the effects of anesthetics on Circulatory Function Genomics and&#xD;
      find the anesthetic effects in pharmacodynamics, pharmacokinetics, drug receptor or target&#xD;
      DNA level differences, further guiding individual treatment in clinic, promoting the&#xD;
      development of precision the medicine.The anesthesia medication during perioperative period&#xD;
      is more and more accurate,reasonable and safe, so as to improve the satisfaction of the&#xD;
      patients and their families in the perioperative period, to ensure the safety of patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a non traumatic and non intervention study, and will use a large sample of&#xD;
      clinical research, the number of subjects to be enrolled in the study group are 200 cases.&#xD;
      The basic information of the study was included in the study before the operation. During the&#xD;
      operation, the investigators need a collection of participants's arterial blood and monitor&#xD;
      the hemodynamic index and anesthesia depth by bispectral index(BIS) . Further more，the&#xD;
      investigators will follow up the participants' condition after operation.Dividing the&#xD;
      patients into different groups according to their clinical features.The relationship between&#xD;
      vital signs and the depth of anesthesia was analyzed and compared between different&#xD;
      groups.Blood samples collected during the operation were detected by gene test. Comparing the&#xD;
      results of genetic testing and clinical data analysis, then the investigators will find the&#xD;
      differences in the expression of the gene polymorphisms of anesthetic drugs in the&#xD;
      circulating function.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2016</start_date>
  <completion_date type="Actual">April 2019</completion_date>
  <primary_completion_date type="Actual">December 2018</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>Genotyping results of anesthetic drugs</measure>
    <time_frame>one year</time_frame>
    <description>Genotype information of SNP related to anesthetic drug metabolism, such as AA, AG or GG</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>vital signs</measure>
    <time_frame>one year</time_frame>
    <description>The percentage of change in mean arterial pressure and heart rate</description>
  </secondary_outcome>
  <other_outcome>
    <measure>depth of anesthesia</measure>
    <time_frame>one year</time_frame>
    <description>The value of BIS</description>
  </other_outcome>
  <other_outcome>
    <measure>prognostic indicator</measure>
    <time_frame>one year</time_frame>
    <description>The days of patients' hospital stay time</description>
  </other_outcome>
  <enrollment type="Actual">223</enrollment>
  <condition>Drug Reaction</condition>
  <condition>Anesthetic</condition>
  <condition>Hemodynamic Rebound</condition>
  <condition>Gene</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      whole blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients from department of thoracic and cardiovascular surgery in Xiangya Hospital,&#xD;
        Central South University&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Undergoing general anesthesia&#xD;
&#xD;
          -  Undergoing Cardiovascular surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA granding more than five&#xD;
&#xD;
          -  Severe organ dysfunction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>e wang, doctor</last_name>
    <role>Study Chair</role>
    <affiliation>Xiangya Hospital of Central South University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Xiangya Hospital of Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>December 13, 2017</study_first_submitted>
  <study_first_submitted_qc>February 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 27, 2022</last_update_submitted>
  <last_update_submitted_qc>February 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>personalized medicine</keyword>
  <keyword>genetic polymorphism</keyword>
  <keyword>pharmacogenetics</keyword>
  <keyword>hemodynamic change</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Drug-Related Side Effects and Adverse Reactions</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/NCT03839186
org study id: XYHMZK PG 2000
nct id: NCT03839186
lead sponsor: 
This study intends to study the effects of anesthetics on Circulatory Function Genomics and
      find the anesthetic effects in pharmacodynamics, pharmacokinetics, drug receptor or target
      DNA level differences, further guiding individual treatment in clinic, promoting the
      development of precision the medicine.The anesthesia medication during perioperative period
      is more and more accurate,reasonable and safe, so as to improve the satisfaction of the
      patients and their families in the perioperative period, to ensure the safety of patients.
This study is a non traumatic and non intervention study, and will use a large sample of
      clinical research, the number of subjects to be enrolled in the study group are 200 cases.
      The basic information of the study was included in the study before the operation. During the
      operation, the investigators need a collection of participants's arterial blood and monitor
      the hemodynamic index and anesthesia depth by bispectral index(BIS) . Further more，the
      investigators will follow up the participants' condition after operation.Dividing the
      patients into different groups according to their clinical features.The relationship between
      vital signs and the depth of anesthesia was analyzed and compared between different
      groups.Blood samples collected during the operation were detected by gene test. Comparing the
      results of genetic testing and clinical data analysis, then the investigators will find the
      differences in the expression of the gene polymorphisms of anesthetic drugs in the
      circulating function.
observational model: Case-Only
time perspective: Prospective
measure: Genotyping results of anesthetic drugs
time frame: one year
description: Genotype information of SNP related to anesthetic drug metabolism, such as AA, AG or GG
measure: vital signs
time frame: one year
description: The percentage of change in mean arterial pressure and heart rate
measure: depth of anesthesia
time frame: one year
description: The value of BIS
measure: prognostic indicator
time frame: one year
description: The days of patients' hospital stay time
whole blood
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: e wang, doctor
role: Study Chair
affiliation: Xiangya Hospital of Central South University
facility: 
country: China
responsible party type: Sponsor
mesh term: Drug-Related Side Effects and Adverse Reactions
sharing ipd: No