<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/NCT02973724</url>
  </required_header>
  <id_info>
    <org_study_id>AJIRB-MED-CT4-16-349</org_study_id>
    <nct_id>NCT02973724</nct_id>
  </id_info>
  <brief_title>EC95 of Remifentanil for Preventing Cough</brief_title>
  <official_title>Predicted EC95 of Effect-site Concentration of Remifentanil for Preventing Cough After Laryngomicrosurgery From Propofol Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ajou University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ajou University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigator designed this study to investigate remifentanil effect-site concentration in&#xD;
      95% of patients (EC95) for preventing cough after laryngomicrosurgery from propofol&#xD;
      anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At the end of the surgery, propofol infusion was stopped and remifentanil was titrated to&#xD;
      predetermined (initial concentration 1.0 ng/ml for the first patient). Extubation was&#xD;
      performed when the patients opened their eyes and spontaneous respiration and adequate tidal&#xD;
      volume and ventilatory frequency were confirmed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of cough</measure>
    <time_frame>from end of surgery to 5 min after tracheal extubation</time_frame>
    <description>Number of cough or a strong and sudden contraction of the abdomen during periextubation periods</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Drug Usage</condition>
  <arm_group>
    <arm_group_label>Remifentanil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Extubation was performed when remifentanil was maintained a predetermined concentration throughout the emergence periods.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Remifentanil</intervention_name>
    <description>The concentration of remifentanil was determined by biased-coin up and down design, starting from 1.0 ng/ml (0.4 ng/ml as a step size)</description>
    <arm_group_label>Remifentanil</arm_group_label>
    <other_name>Ultiva</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol anesthesia</intervention_name>
    <description>Anesthesia was induced with propofol target-controlled infusion at an effect-site concentration of 5.0 μg/ml.</description>
    <arm_group_label>Remifentanil</arm_group_label>
    <other_name>Fresofol</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I-II patients undergoing general anesthesia for laryngomicrosurgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anticipated difficult airway&#xD;
&#xD;
          -  COPD, Asthma&#xD;
&#xD;
          -  Recent URI (&lt; 2 weeks)&#xD;
&#xD;
          -  Severe cardiac, hepatic renal disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ajou University Hospital</name>
      <address>
        <city>Suwon</city>
        <state>Gyeonggi-do</state>
        <zip>443-721</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>June 8, 2017</last_update_submitted>
  <last_update_submitted_qc>June 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ajou University School of Medicine</investigator_affiliation>
    <investigator_full_name>Jong Yeop Kim</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Extubation</keyword>
  <keyword>Remifentanil</keyword>
  <keyword>Laryngomicrosurgery</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Remifentanil</mesh_term>
    <mesh_term>Propofol</mesh_term>
  </intervention_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/NCT02973724
org study id: AJIRB-MED-CT4-16-349
nct id: NCT02973724
lead sponsor: 
has dmc: Yes
The investigator designed this study to investigate remifentanil effect-site concentration in
      95% of patients (EC95) for preventing cough after laryngomicrosurgery from propofol
      anesthesia.
At the end of the surgery, propofol infusion was stopped and remifentanil was titrated to
      predetermined (initial concentration 1.0 ng/ml for the first patient). Extubation was
      performed when the patients opened their eyes and spontaneous respiration and adequate tidal
      volume and ventilatory frequency were confirmed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of cough
time frame: from end of surgery to 5 min after tracheal extubation
description: Number of cough or a strong and sudden contraction of the abdomen during periextubation periods
arm group label: Remifentanil
arm group type: Experimental
description: Extubation was performed when remifentanil was maintained a predetermined concentration throughout the emergence periods.
intervention type: Drug
intervention name: Remifentanil
description: The concentration of remifentanil was determined by biased-coin up and down design, starting from 1.0 ng/ml (0.4 ng/ml as a step size)
arm group label: Remifentanil
other name: Ultiva
intervention type: Drug
intervention name: Propofol anesthesia
description: Anesthesia was induced with propofol target-controlled infusion at an effect-site concentration of 5.0 μg/ml.
arm group label: Remifentanil
other name: Fresofol
criteria: 
gender: All
minimum age: 19 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Ajou University School of Medicine
investigator full name: Jong Yeop Kim
investigator title: Professor
mesh term: Remifentanil
mesh term: Propofol
sharing ipd: No