<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/NCT02208505</url>
  </required_header>
  <id_info>
    <org_study_id>3-2013-0192'</org_study_id>
    <nct_id>NCT02208505</nct_id>
  </id_info>
  <brief_title>Antitussive Effect of Single-dose Dexmedetomidine With Low-dose Remifentanil Infusion</brief_title>
  <official_title>Antitussive Effect of Single-dose Dexmedetomidine With Low-dose Remifentanil Infusion During Emergence in Adults After Thyroidectomy: Comparison With High-dose Remifentanil Infusion Alone</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <brief_summary>
    <textblock>
      After thyroid surgery, the incidence and severity of coughing is important because it may&#xD;
      cause serious complications, such as bleeding in the surgical field, laryngospasm, and&#xD;
      cardiovascular disturbance. Several studies have shown that the single-dose of&#xD;
      dexmedetomidine is effective for reducing cough and agitation during emergence from general&#xD;
      anesthesia.&#xD;
&#xD;
      To test the hypothesis that single-dose of dexmedetomidine combined with a low-dose&#xD;
      remifentanil infusion during emergence from general anaesthesia could reduce coughing as good&#xD;
      as high-dose remifentanil infusion, we will evaluate the efficacy on cough suppression and&#xD;
      reduction of side effect of remifentanil using non-inferiority trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of coughing during emergence from general anesthesia</measure>
    <time_frame>from 5min before extubation to 5min after extubation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>side effect of remifentanil</measure>
    <time_frame>up to 1 day after surgery</time_frame>
    <description>comparison of the incidence of delayed awakening, post-operative nausea/vomiting, consumption of pain killer</description>
  </secondary_outcome>
  <other_outcome>
    <measure>quality of recovery from anesthesia</measure>
    <time_frame>upto 1day after surgery</time_frame>
    <description>using Quality of Recovery-40 questionnaire, evaluate the recovery status of patient from general anesthesia</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">168</enrollment>
  <condition>Thyroidectomy</condition>
  <arm_group>
    <arm_group_label>Dexmedetomidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>we administrate the single-dose dexmedetomidine (0.5mcg/kg) with low-dose remifentanil infusion(TCI 1 ng/ml).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Remifentanil</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>we administrate the high-dose remifentanil infusion(TCI 2 ng/ml) alone.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine + Remifentanil-low dose</intervention_name>
    <description>single dose administration (0.5mcg/kg) 10 min before end of the surgery with maintain the infusion of remifentanil (TCI 1 ng/ml) until end of surgery</description>
    <arm_group_label>Dexmedetomidine</arm_group_label>
    <other_name>Precedex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Remifentanil-high dose</intervention_name>
    <description>maintain the infusion of remifentanil until end of the surgery (TCI 2 ng/ml)</description>
    <arm_group_label>Remifentanil</arm_group_label>
    <other_name>Ultiva</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Thyroid disease undergoing thyroidectomy&#xD;
&#xD;
          -  age 20-65&#xD;
&#xD;
          -  Amerian society of anesthesgiologist class 1 or 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chronic cough&#xD;
&#xD;
          -  difficult intubation&#xD;
&#xD;
          -  liver disease&#xD;
&#xD;
          -  uncontrolled hypertension&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeong Soo Lee</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yonsei University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gangnam severance hospital</name>
      <address>
        <city>Seoul</city>
        <zip>135-720</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>February 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>October 17, 2017</last_update_submitted>
  <last_update_submitted_qc>October 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yonsei University</investigator_affiliation>
    <investigator_full_name>Jeong Soo Lee</investigator_full_name>
    <investigator_title>Clinical Assistant Professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</mesh_term>
    <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/NCT02208505
org study id: 3-2013-0192'
nct id: NCT02208505
lead sponsor: 
After thyroid surgery, the incidence and severity of coughing is important because it may
      cause serious complications, such as bleeding in the surgical field, laryngospasm, and
      cardiovascular disturbance. Several studies have shown that the single-dose of
      dexmedetomidine is effective for reducing cough and agitation during emergence from general
      anesthesia.

      To test the hypothesis that single-dose of dexmedetomidine combined with a low-dose
      remifentanil infusion during emergence from general anaesthesia could reduce coughing as good
      as high-dose remifentanil infusion, we will evaluate the efficacy on cough suppression and
      reduction of side effect of remifentanil using non-inferiority trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Incidence of coughing during emergence from general anesthesia
time frame: from 5min before extubation to 5min after extubation
measure: side effect of remifentanil
time frame: up to 1 day after surgery
description: comparison of the incidence of delayed awakening, post-operative nausea/vomiting, consumption of pain killer
measure: quality of recovery from anesthesia
time frame: upto 1day after surgery
description: using Quality of Recovery-40 questionnaire, evaluate the recovery status of patient from general anesthesia
arm group label: Dexmedetomidine
arm group type: Experimental
description: we administrate the single-dose dexmedetomidine (0.5mcg/kg) with low-dose remifentanil infusion(TCI 1 ng/ml).
arm group label: Remifentanil
arm group type: Active Comparator
description: we administrate the high-dose remifentanil infusion(TCI 2 ng/ml) alone.
intervention type: Drug
intervention name: Dexmedetomidine + Remifentanil-low dose
description: single dose administration (0.5mcg/kg) 10 min before end of the surgery with maintain the infusion of remifentanil (TCI 1 ng/ml) until end of surgery
arm group label: Dexmedetomidine
other name: Precedex
intervention type: Drug
intervention name: Remifentanil-high dose
description: maintain the infusion of remifentanil until end of the surgery (TCI 2 ng/ml)
arm group label: Remifentanil
other name: Ultiva
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jeong Soo Lee
role: Principal Investigator
affiliation: Yonsei University
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Yonsei University
investigator full name: Jeong Soo Lee
investigator title: Clinical Assistant Professor
mesh term: Dexmedetomidine
mesh term: Remifentanil