<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/NCT01683916</url>
  </required_header>
  <id_info>
    <org_study_id>2010-12-198</org_study_id>
    <nct_id>NCT01683916</nct_id>
  </id_info>
  <brief_title>Anesthetic Requirement and Stress Hormone Response During Surgery in Spinal Cord-injured Patients</brief_title>
  <official_title>Chonnam National University Hospital IRB</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chonnam National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chonnam National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Spinal cord injury (SCI) reduces anesthetic requirements and stress hormonal responses.&#xD;
      Anesthetic requirements and stress hormone response are compared in SCI patients undergoing&#xD;
      anesthesia with sevoflurane supplemented with clinically equivalent doses of either N2O or&#xD;
      remifentanil.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nitrous oxide (N2O) is often used for anesthetic adjuvant, but may be associated with side&#xD;
      effects and toxicities. Remifentanil shares characteristics with N2O, including&#xD;
      anesthetic-reducing and antinociceptive effects and a rapid recovery. Anesthetic requirements&#xD;
      and stress hormone response in SCI patients undergoing anesthesia with sevoflurane&#xD;
      supplemented with clinically equivalent doses of either N2O or remifentanil. Forty-five SCI&#xD;
      patients scheduled to undergo pressor sore surgery below the level of the injury are randomly&#xD;
      allocated to receive either sevoflurane alone (control, n=15), or combined with 67% N2O&#xD;
      (n=15) or target-controlled infusions of 1.37 ng/mL remifentanil (n=15). Sevoflurane&#xD;
      concentration is titrated to maintain a Bispectral Index (BIS) value of 40-50. Measurements&#xD;
      include end-tidal sevoflurane concentrations, mean arterial blood pressure (MAP), heart rate&#xD;
      (HR), and plasma catecholamine and cortisol concentrations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2011</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <enrollment type="Actual">45</enrollment>
  <condition>Complete Spinal Cord Injury</condition>
  <condition>Surgery</condition>
  <eligibility>
    <study_pop>
      <textblock>
        ASA physical status II, with chronic, clinically complete cord injuries scheduled for a&#xD;
        surgery for pressure sore below the level of the neurologic lesion under general&#xD;
        anesthesia.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA physical status II, with chronic, clinically complete cord injuries scheduled for&#xD;
             a surgery for pressure sore below the level of the neurologic lesion under general&#xD;
             anesthesia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiovascular, pulmonary, or metabolic diseases. Patients who took medications that&#xD;
             would influence autonomic or cardiovascular responses to the surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Anesthesiology and Pain Medicine</name>
      <address>
        <city>Gwangju</city>
        <zip>501-757</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>December 2010</verification_date>
  <study_first_submitted>September 8, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <last_update_submitted>July 19, 2017</last_update_submitted>
  <last_update_submitted_qc>July 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chonnam National University Hospital</investigator_affiliation>
    <investigator_full_name>Kyung Yeon Yoo</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>spinal cord injury</keyword>
  <keyword>stress hormone</keyword>
  <keyword>surgery</keyword>
  <keyword>bispectral index value</keyword>
  <keyword>volatile anesthetic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
  </condition_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/NCT01683916
org study id: 2010-12-198
nct id: NCT01683916
lead sponsor: 
has dmc: No
Spinal cord injury (SCI) reduces anesthetic requirements and stress hormonal responses.
      Anesthetic requirements and stress hormone response are compared in SCI patients undergoing
      anesthesia with sevoflurane supplemented with clinically equivalent doses of either N2O or
      remifentanil.
Nitrous oxide (N2O) is often used for anesthetic adjuvant, but may be associated with side
      effects and toxicities. Remifentanil shares characteristics with N2O, including
      anesthetic-reducing and antinociceptive effects and a rapid recovery. Anesthetic requirements
      and stress hormone response in SCI patients undergoing anesthesia with sevoflurane
      supplemented with clinically equivalent doses of either N2O or remifentanil. Forty-five SCI
      patients scheduled to undergo pressor sore surgery below the level of the injury are randomly
      allocated to receive either sevoflurane alone (control, n=15), or combined with 67% N2O
      (n=15) or target-controlled infusions of 1.37 ng/mL remifentanil (n=15). Sevoflurane
      concentration is titrated to maintain a Bispectral Index (BIS) value of 40-50. Measurements
      include end-tidal sevoflurane concentrations, mean arterial blood pressure (MAP), heart rate
      (HR), and plasma catecholamine and cortisol concentrations.
observational model: Case-Control
time perspective: Prospective
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 10 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Chonnam National University Hospital
investigator full name: Kyung Yeon Yoo
investigator title: Professor
mesh term: Spinal Cord Injuries