<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/NCT01735019</url>
  </required_header>
  <id_info>
    <org_study_id>4-2012-0350</org_study_id>
    <nct_id>NCT01735019</nct_id>
  </id_info>
  <brief_title>Estimating EC95 of Remifentanil for Cough Prevention During Emergence From Total Intravenous Anesthesia With Propofol and Remifentanil in Patients Undergoing Transsphenoidal Hypophysectomy</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In patients undergoing hypophysectomy through transsphenoidal approach, preventing cough&#xD;
      during anesthetic emergence is important to avoid hemorrhage and cerebrospinal fluid leakage.&#xD;
      Previous reports demonstrated that administration of remifentanil during anesthetic emergence&#xD;
      could reduce the incidence and severity of cough during anesthetic emergence. Therefore, the&#xD;
      objective of this study is to determine EC95 of remifentanil for preventing cough during&#xD;
      anesthetic emergence in patients undergoing hypophysectomy with transsphenoidal approach.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The occurrence of cough during anesthetic emergence</measure>
    <time_frame>5 min after extubation</time_frame>
    <description>At a given effect-site concentration of remifentanil, if cough does not occur during anesthetic emergence, it would be considered as a success. On the other hand, if cough occurs during anesthetic emergence, it would be considered as a failure.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Hypophysectomy</condition>
  <arm_group>
    <arm_group_label>group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>administration of remifentanil with target-controlled infusion (TCI) system at a given concentration during anesthetic emergence</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Administration of remifentanil with TCI system</intervention_name>
    <description>A given effect site concentration of remifentanil would be administered to subjects using TCI system. According to biased coin design, the given concentration of remifentanil is determined according to success or failure of just previously enrolled patient. If the former patient did not cough during anesthetic emergence at a given concentration (success), the next patient will be randomly allocated into the same concentration of remifentanil with 18/19 of probability or the lower concentration of remifentanil by 0.4 ng/ml with 1/19 of probability. If the former patient coughed during anesthetic emergence (failure), the next will be automatically allocated into the higher concentration of remifentanil by 0.4 ng/ml.</description>
    <arm_group_label>group 1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  scheduled to undergo hypophysectomy with transsphenoidal approach&#xD;
&#xD;
          -  American Society of Anesthesiologists physical status I or II&#xD;
&#xD;
          -  more than 20 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute or chronic respiratory disease&#xD;
&#xD;
          -  uncontrolled hypertension&#xD;
&#xD;
          -  taking sedatives or anti-tussive&#xD;
&#xD;
          -  gastro-esophageal reflux&#xD;
&#xD;
          -  pregnant or breast feeding&#xD;
&#xD;
          -  patients who cannot understand statements for subjects or this study itself&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 18, 2012</study_first_submitted>
  <study_first_submitted_qc>November 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <last_update_submitted>September 17, 2013</last_update_submitted>
  <last_update_submitted_qc>September 17, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 18, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>EC95, effective concentration in 95% of subjects</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Remifentanil</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/NCT01735019
org study id: 4-2012-0350
nct id: NCT01735019
lead sponsor: 
has dmc: No
In patients undergoing hypophysectomy through transsphenoidal approach, preventing cough
      during anesthetic emergence is important to avoid hemorrhage and cerebrospinal fluid leakage.
      Previous reports demonstrated that administration of remifentanil during anesthetic emergence
      could reduce the incidence and severity of cough during anesthetic emergence. Therefore, the
      objective of this study is to determine EC95 of remifentanil for preventing cough during
      anesthetic emergence in patients undergoing hypophysectomy with transsphenoidal approach.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: The occurrence of cough during anesthetic emergence
time frame: 5 min after extubation
description: At a given effect-site concentration of remifentanil, if cough does not occur during anesthetic emergence, it would be considered as a success. On the other hand, if cough occurs during anesthetic emergence, it would be considered as a failure.
arm group label: group 1
arm group type: Experimental
description: administration of remifentanil with target-controlled infusion (TCI) system at a given concentration during anesthetic emergence
intervention type: Drug
intervention name: Administration of remifentanil with TCI system
description: A given effect site concentration of remifentanil would be administered to subjects using TCI system. According to biased coin design, the given concentration of remifentanil is determined according to success or failure of just previously enrolled patient. If the former patient did not cough during anesthetic emergence at a given concentration (success), the next patient will be randomly allocated into the same concentration of remifentanil with 18/19 of probability or the lower concentration of remifentanil by 0.4 ng/ml with 1/19 of probability. If the former patient coughed during anesthetic emergence (failure), the next will be automatically allocated into the higher concentration of remifentanil by 0.4 ng/ml.
arm group label: group 1
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Remifentanil