<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/NCT02252419</url>
  </required_header>
  <id_info>
    <org_study_id>SoreThroatParacetamol</org_study_id>
    <nct_id>NCT02252419</nct_id>
  </id_info>
  <brief_title>Combined Effect of Dexamethasone and Paracetamol for Postoperative Sore Throat</brief_title>
  <official_title>Combined Effect of Preoperative Dexamethasone and Intraoperative Paracetamol on Postoperative Sore Throat for Patients Undergoing Urologic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators want to evaluate the efficacy of the dexamethasone and paracetamol for the&#xD;
      prevention of postoperative sore throat.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The postoperative sore throat is a common complication after the general anesthesia which&#xD;
      decreases the quality of life. Dexamethasone is known to effective for the prevention of&#xD;
      postoperative sore throat. The combined effect of the dexamethasone and paracetamol for&#xD;
      postoperative sore throat, however, is not investigated.&#xD;
&#xD;
      The investigators want to evaluate the efficacy of the dexamethasone and paracetamol for the&#xD;
      prevention of postoperative sore throat.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">March 2015</completion_date>
  <primary_completion_date type="Anticipated">February 2015</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>Postoperative sore throat</measure>
    <time_frame>1 hour postoperatively</time_frame>
    <description>Postoperative sore throat after 1 hour postoperatively will be measured (0:none, 1:mild, 2:moderate, 3:severe)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative sore throat degree</measure>
    <time_frame>0, 1, 6, 24 hour postoperatively</time_frame>
    <description>Postoperative sore throat degree after 0, 1, 6, 24 hour postoperatively will be measured (11 points, 0:none, 10:worst imaginable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>0, 1, 6, 24 hour postoperatively</time_frame>
    <description>Postoperative pain after 0, 1, 6, 24 hour postoperatively will be measured (11 points, 0:none, 10:worst imaginable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nausea</measure>
    <time_frame>0, 1, 6, 24 hour postoperatively</time_frame>
    <description>Nausea will be measured at 0, 1, 6 and 24 hour postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vomiting</measure>
    <time_frame>0, 1, 6, 24 hour postoperatively</time_frame>
    <description>Vomiting will be measured at 0, 1, 6 and 24 hour postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Somnolence</measure>
    <time_frame>0, 1, 6, 24 hour postoperatively</time_frame>
    <description>Somnolence will be measured at 0, 1, 6 and 24 hour postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shivering</measure>
    <time_frame>0, 1, 6, 24 hour postoperatively</time_frame>
    <description>Shivering will be measured at 0, 1, 6 and 24 hour postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Headache</measure>
    <time_frame>0, 1, 6, 24 hour postoperatively</time_frame>
    <description>Headache will be measured at 0, 1, 6 and 24 hour postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hoarseness</measure>
    <time_frame>0, 1, 6, 24 hour postoperatively</time_frame>
    <description>Hoarseness will be measured at 0, 1, 6 and 24 hour postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dysphagia</measure>
    <time_frame>0, 1, 6, 24 hour postoperatively</time_frame>
    <description>Dysphagia will be measured at 0, 1, 6 and 24 hour postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analgesics</measure>
    <time_frame>0, 1, 6, 24 hour postoperatively</time_frame>
    <description>Analgesics usage will be measured at 0, 1, 6 and 24 hour postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative sore throat</measure>
    <time_frame>0, 6, 24 hour postoperatively</time_frame>
    <description>Postoperative sore throat after 0, 6, 24 hour postoperatively will be measured (0:none, 1:mild, 2:moderate, 3:severe)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">242</enrollment>
  <condition>Pharyngitis</condition>
  <arm_group>
    <arm_group_label>Dexamethasone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dexamethasone will be administered 30 minutes before the anesthetic induction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dexamethasone+ Paracetamol (DP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dexamethasone will be administered 30 minutes before the anesthetic induction. Paracetamol will be administered at the end of the surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Dexamethasone will be administered.</description>
    <arm_group_label>Dexamethasone</arm_group_label>
    <arm_group_label>Dexamethasone+ Paracetamol (DP)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paracetamol</intervention_name>
    <description>Paracetamol will be administered.</description>
    <arm_group_label>Dexamethasone+ Paracetamol (DP)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for urologic surgery under general anesthesia&#xD;
&#xD;
          -  ASA I-III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with recent sore throat&#xD;
&#xD;
          -  Patients with neck surgery&#xD;
&#xD;
          -  Patients with anticipated difficult airway&#xD;
&#xD;
          -  Patients with Mallampati grade 3&#xD;
&#xD;
          -  Patients with severe cardiovascular or pulmonary disease&#xD;
&#xD;
          -  Patients with allergic history to dexamethasone or paracetamol&#xD;
&#xD;
          -  Patients with liver function disorder&#xD;
&#xD;
          -  Patients with liver disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hee-Pyoung Park, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University of Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hyun-Chang Kim, MD</last_name>
    <phone>82-10-2886-2876</phone>
    <email>onidori1979@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seolu National University of Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <contact>
      <last_name>Hyun-Chang Kim, MD</last_name>
      <phone>83-10-2886-2876</phone>
      <email>onidori1979@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <last_update_submitted>October 16, 2014</last_update_submitted>
  <last_update_submitted_qc>October 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 17, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Postoperative Period</keyword>
  <keyword>Anesthesia, General</keyword>
  <keyword>Intubation, Intratracheal</keyword>
  <keyword>Dexamethasone</keyword>
  <keyword>Acetaminophen</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>Acetaminophen</mesh_term>
    <mesh_term>Dexamethasone</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/NCT02252419
org study id: SoreThroatParacetamol
nct id: NCT02252419
lead sponsor: 
has dmc: Yes
The investigators want to evaluate the efficacy of the dexamethasone and paracetamol for the
      prevention of postoperative sore throat.
The postoperative sore throat is a common complication after the general anesthesia which
      decreases the quality of life. Dexamethasone is known to effective for the prevention of
      postoperative sore throat. The combined effect of the dexamethasone and paracetamol for
      postoperative sore throat, however, is not investigated.

      The investigators want to evaluate the efficacy of the dexamethasone and paracetamol for the
      prevention of postoperative sore throat.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Postoperative sore throat
time frame: 1 hour postoperatively
description: Postoperative sore throat after 1 hour postoperatively will be measured (0:none, 1:mild, 2:moderate, 3:severe)
measure: Postoperative sore throat degree
time frame: 0, 1, 6, 24 hour postoperatively
description: Postoperative sore throat degree after 0, 1, 6, 24 hour postoperatively will be measured (11 points, 0:none, 10:worst imaginable).
measure: Postoperative pain
time frame: 0, 1, 6, 24 hour postoperatively
description: Postoperative pain after 0, 1, 6, 24 hour postoperatively will be measured (11 points, 0:none, 10:worst imaginable).
measure: Nausea
time frame: 0, 1, 6, 24 hour postoperatively
description: Nausea will be measured at 0, 1, 6 and 24 hour postoperatively.
measure: Vomiting
time frame: 0, 1, 6, 24 hour postoperatively
description: Vomiting will be measured at 0, 1, 6 and 24 hour postoperatively.
measure: Somnolence
time frame: 0, 1, 6, 24 hour postoperatively
description: Somnolence will be measured at 0, 1, 6 and 24 hour postoperatively.
measure: Shivering
time frame: 0, 1, 6, 24 hour postoperatively
description: Shivering will be measured at 0, 1, 6 and 24 hour postoperatively.
measure: Headache
time frame: 0, 1, 6, 24 hour postoperatively
description: Headache will be measured at 0, 1, 6 and 24 hour postoperatively.
measure: Hoarseness
time frame: 0, 1, 6, 24 hour postoperatively
description: Hoarseness will be measured at 0, 1, 6 and 24 hour postoperatively.
measure: Dysphagia
time frame: 0, 1, 6, 24 hour postoperatively
description: Dysphagia will be measured at 0, 1, 6 and 24 hour postoperatively.
measure: Analgesics
time frame: 0, 1, 6, 24 hour postoperatively
description: Analgesics usage will be measured at 0, 1, 6 and 24 hour postoperatively.
measure: Postoperative sore throat
time frame: 0, 6, 24 hour postoperatively
description: Postoperative sore throat after 0, 6, 24 hour postoperatively will be measured (0:none, 1:mild, 2:moderate, 3:severe)
arm group label: Dexamethasone
arm group type: Active Comparator
description: Dexamethasone will be administered 30 minutes before the anesthetic induction.
arm group label: Dexamethasone+ Paracetamol (DP)
arm group type: Experimental
description: Dexamethasone will be administered 30 minutes before the anesthetic induction. Paracetamol will be administered at the end of the surgery.
intervention type: Drug
intervention name: Dexamethasone
description: Dexamethasone will be administered.
arm group label: Dexamethasone
arm group label: Dexamethasone+ Paracetamol (DP)
intervention type: Drug
intervention name: Paracetamol
description: Paracetamol will be administered.
arm group label: Dexamethasone+ Paracetamol (DP)
criteria: 
gender: All
minimum age: 19 Years
maximum age: 80 Years
healthy volunteers: No
last name: Hee-Pyoung Park, PhD
role: Principal Investigator
affiliation: Seoul National University of Hospital
last name: Hyun-Chang Kim, MD
phone: 82-10-2886-2876
email: onidori1979@gmail.com
facility: 
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Pharyngitis
mesh term: Acetaminophen
mesh term: Dexamethasone