<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/NCT03805568</url>
  </required_header>
  <id_info>
    <org_study_id>YUMC 2017-03-037</org_study_id>
    <nct_id>NCT03805568</nct_id>
  </id_info>
  <brief_title>A Postoperative Sore Throat After Thyroidectomy</brief_title>
  <official_title>The Effect of Dexmedetomidine and Remifentanil on the Postoperative Sore Throat After Thyroidectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yeungnam University College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yeungnam University College of Medicine</source>
  <oversight_info>
    <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 was performed to compare the effect on of a postoperative sore throat between&#xD;
      dexmedetomidine and remifentanil in patients undergoing thyroidectomy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 5, 2017</start_date>
  <completion_date type="Actual">July 25, 2018</completion_date>
  <primary_completion_date type="Actual">July 3, 2018</primary_completion_date>
  <phase>N/A</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of postoperative sore throat at rest</measure>
    <time_frame>6 hours after surgery</time_frame>
    <description>0=none; 1=occur</description>
  </primary_outcome>
  <primary_outcome>
    <measure>incidence of postoperative sore throat at swallowing</measure>
    <time_frame>6 hours after surgery</time_frame>
    <description>0=none; 1=occur</description>
  </primary_outcome>
  <primary_outcome>
    <measure>severity of postoperative sore throat at rest</measure>
    <time_frame>6 hours after surgery</time_frame>
    <description>4-point scale (0=none; 1=mild; 2=moderate; 3=severe)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>severity of postoperative sore throat at swallowing</measure>
    <time_frame>6 hours after surgery</time_frame>
    <description>4-point scale (0=none; 1=mild; 2=moderate; 3=severe)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Post Operative Sore Throat</condition>
  <arm_group>
    <arm_group_label>dexmedetomidine infusion group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>dexmedetomidine infusion (loading dose of 1 ㎍/kg over 10 min and continuous infusion of 0.3-0.6 ㎍/kg/h) during the surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>remifentanil infusion group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>remifentanil of 4 ng/ml during induction, followed by remifentanil infusion (1.5~2.5 ng/ml) during the surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dexmedetomidine infusion group</intervention_name>
    <description>dexmedetomidine as anaesthetic adjuvant</description>
    <arm_group_label>dexmedetomidine infusion group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>remifentanil infusion group</intervention_name>
    <description>remifentanil as anaesthetic adjuvant</description>
    <arm_group_label>remifentanil infusion group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who scheduled primary thyroidectomy were enrolled and their physical status&#xD;
             was American Society of Anesthesiologists (ASA) class 1 or 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with respiratory tract disease, previous head, and neck surgery, preexisting&#xD;
             steroid or non-steroidal anti-inflammatory drug use, and known or suspected difficult&#xD;
             airway&#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>Eun kyung Choi</name>
      <address>
        <city>Daegu</city>
        <state>Korea (the Republic Of)</state>
        <zip>41944</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 13, 2019</last_update_submitted>
  <last_update_submitted_qc>January 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yeungnam University College of Medicine</investigator_affiliation>
    <investigator_full_name>Eun Kyung Choi</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>postoperative sore throat</keyword>
  <keyword>dexmedetomidine</keyword>
  <keyword>remifentanil</keyword>
  <keyword>thyroidectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pharyngitis</mesh_term>
  </condition_browse>
  <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>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03805568
org study id: YUMC 2017-03-037
nct id: NCT03805568
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study was performed to compare the effect on of a postoperative sore throat between
      dexmedetomidine and remifentanil in patients undergoing thyroidectomy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: incidence of postoperative sore throat at rest
time frame: 6 hours after surgery
description: 0=none; 1=occur
measure: incidence of postoperative sore throat at swallowing
time frame: 6 hours after surgery
description: 0=none; 1=occur
measure: severity of postoperative sore throat at rest
time frame: 6 hours after surgery
description: 4-point scale (0=none; 1=mild; 2=moderate; 3=severe)
measure: severity of postoperative sore throat at swallowing
time frame: 6 hours after surgery
description: 4-point scale (0=none; 1=mild; 2=moderate; 3=severe)
arm group label: dexmedetomidine infusion group
arm group type: Active Comparator
description: dexmedetomidine infusion (loading dose of 1 ㎍/kg over 10 min and continuous infusion of 0.3-0.6 ㎍/kg/h) during the surgery
arm group label: remifentanil infusion group
arm group type: Active Comparator
description: remifentanil of 4 ng/ml during induction, followed by remifentanil infusion (1.5~2.5 ng/ml) during the surgery
intervention type: Drug
intervention name: dexmedetomidine infusion group
description: dexmedetomidine as anaesthetic adjuvant
arm group label: dexmedetomidine infusion group
intervention type: Drug
intervention name: remifentanil infusion group
description: remifentanil as anaesthetic adjuvant
arm group label: remifentanil infusion group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Yeungnam University College of Medicine
investigator full name: Eun Kyung Choi
investigator title: Professor
mesh term: Pharyngitis
mesh term: Dexmedetomidine
mesh term: Remifentanil
sharing ipd: Yes