<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/NCT03233815</url>
  </required_header>
  <id_info>
    <org_study_id>R-2017-3604-95</org_study_id>
    <nct_id>NCT03233815</nct_id>
  </id_info>
  <brief_title>Benefits of Total Intravenous Anesthesia Compared With Inhaled Anesthesia in Cardiovascular Surgery</brief_title>
  <official_title>Benefits of Total Intravenous Anesthesia Compared With Inhaled Anesthesia in Cardiovascular Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Coordinación de Investigación en Salud, Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Coordinación de Investigación en Salud, Mexico</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>
      This study compares the difference in proinflammatory markers Interleukin 6 (IL-6), Tumor&#xD;
      necrosis factor alpha (TNFα) and cortisol in patients undergoing cardiovascular surgery to&#xD;
      asses if there is a benefit of using intravenous total anesthesia (TIVA) over inhaled&#xD;
      anesthesia for this procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      IL-6, TNFα and cortisol will be measure at the beginning of the cardiovascular surgery and 20&#xD;
      minutes after the cardiovascular bypass ends to calculate the difference between them and&#xD;
      compare if there is any statistical difference between the proinflammatory markers with the&#xD;
      two anesthesia techniques.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">November 13, 2017</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>IL-6</measure>
    <time_frame>The difference between IL-6 at the begging of surgery and 20 minutes after the end of the cardiopulmonary bypass</time_frame>
    <description>IL-6 will be compared between the groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>TNFα</measure>
    <time_frame>The difference between TNFα at the begging of surgery and 20 minutes after the end of the cardiopulmonary bypass</time_frame>
    <description>TNFα will be compared between the groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cortisol</measure>
    <time_frame>The difference between cortisol at the begging of surgery and 20 minutes after the end of the cardiopulmonary bypass</time_frame>
    <description>Cortisol will be compared between the groups</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Cardiovascular Surgical Procedure</condition>
  <arm_group>
    <arm_group_label>Inhaled anesthesia (Sevoflurane)</arm_group_label>
    <description>Patients undergoing cardiovascular surgery with inhaled anesthesia with sevoflurane.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Total Intravenous Anesthesia (Propofol)</arm_group_label>
    <description>Patients undergoing cardiovascular surgery with total intravenous anesthesia with propofol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>Propofol anesthesia Dose: 4-6mg/kg/h</description>
    <arm_group_label>Total Intravenous Anesthesia (Propofol)</arm_group_label>
    <other_name>Diprivan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sevoflurane</intervention_name>
    <description>Inhaled anesthesia with sevoflurane. Dose: 1-2.5 Minimum Alveolar Concentration(MAC)</description>
    <arm_group_label>Inhaled anesthesia (Sevoflurane)</arm_group_label>
    <other_name>Sevorane</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients scheduled for cardiovascular surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Scheduled for cardiovascular surgery American Society of Anaesthesiologists (ASA) physical&#xD;
        status classification II-IV BMI &lt; 25 HbA1c &lt; 7%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Diabetic patients Known allergy to propofol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ana Gallardo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto Mexicano del Seguroa Social</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital de cardiología</name>
      <address>
        <city>Ciudad de mexico</city>
        <state>Cdmx</state>
        <zip>06720</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>August 5, 2020</last_update_submitted>
  <last_update_submitted_qc>August 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Inhaled anesthesia</keyword>
  <keyword>Total intravenous anesthesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Aspiration</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propofol</mesh_term>
    <mesh_term>Sevoflurane</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>The plan is not decided yet.</ipd_description>
  </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/NCT03233815
org study id: R-2017-3604-95
nct id: NCT03233815
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study compares the difference in proinflammatory markers Interleukin 6 (IL-6), Tumor
      necrosis factor alpha (TNFα) and cortisol in patients undergoing cardiovascular surgery to
      asses if there is a benefit of using intravenous total anesthesia (TIVA) over inhaled
      anesthesia for this procedures.
IL-6, TNFα and cortisol will be measure at the beginning of the cardiovascular surgery and 20
      minutes after the cardiovascular bypass ends to calculate the difference between them and
      compare if there is any statistical difference between the proinflammatory markers with the
      two anesthesia techniques.
observational model: Cohort
time perspective: Cross-Sectional
measure: IL-6
time frame: The difference between IL-6 at the begging of surgery and 20 minutes after the end of the cardiopulmonary bypass
description: IL-6 will be compared between the groups.
measure: TNFα
time frame: The difference between TNFα at the begging of surgery and 20 minutes after the end of the cardiopulmonary bypass
description: TNFα will be compared between the groups
measure: Cortisol
time frame: The difference between cortisol at the begging of surgery and 20 minutes after the end of the cardiopulmonary bypass
description: Cortisol will be compared between the groups
arm group label: Inhaled anesthesia (Sevoflurane)
description: Patients undergoing cardiovascular surgery with inhaled anesthesia with sevoflurane.
arm group label: Total Intravenous Anesthesia (Propofol)
description: Patients undergoing cardiovascular surgery with total intravenous anesthesia with propofol.
intervention type: Drug
intervention name: Propofol
description: Propofol anesthesia Dose: 4-6mg/kg/h
arm group label: Total Intravenous Anesthesia (Propofol)
other name: Diprivan
intervention type: Drug
intervention name: Sevoflurane
description: Inhaled anesthesia with sevoflurane. Dose: 1-2.5 Minimum Alveolar Concentration(MAC)
arm group label: Inhaled anesthesia (Sevoflurane)
other name: Sevorane
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: No
last name: Ana Gallardo, PhD
role: Principal Investigator
affiliation: Instituto Mexicano del Seguroa Social
facility: 
country: Mexico
responsible party type: Sponsor
mesh term: Respiratory Aspiration
mesh term: Propofol
mesh term: Sevoflurane
sharing ipd: Undecided
ipd description: The plan is not decided yet.