<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/NCT03259672</url>
  </required_header>
  <id_info>
    <org_study_id>SevoDesPOST</org_study_id>
    <nct_id>NCT03259672</nct_id>
  </id_info>
  <brief_title>Influence of Sevoflurane and Desflurane on Postoperative Sore Throat</brief_title>
  <official_title>Influence of Sevoflurane and Desflurane on Postoperative Sore Throat</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Keimyung University Dongsan Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Keimyung University Dongsan Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This investigation is planned to compare the incidence and severity of postoperative sore&#xD;
      throat according to the use of sevoflurane or desflurane.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2017</start_date>
  <completion_date type="Anticipated">November 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">October 1, 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>Number of participants with postoperative sore throat</measure>
    <time_frame>At 24 hr</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with postoperative sore throat</measure>
    <time_frame>At 0, 2, 4 and 24 hr</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with postoperative hoarseness</measure>
    <time_frame>At 0, 2, 4 and 24 hr</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with postoperative cough</measure>
    <time_frame>At 0, 2, 4 and 24 hr</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with postoperative nausea</measure>
    <time_frame>At 0, 2, 4 and 24 hr</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with postoperative vomiting</measure>
    <time_frame>At 0, 2, 4 and 24 hr</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with additional pain medication</measure>
    <time_frame>At 0, 2, 4 and 24 hr</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual analogue scale of postoperative pain</measure>
    <time_frame>At 0, 2, 4 and 24 hr</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with shivering</measure>
    <time_frame>At 0, 2, 4 and 24 hr</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Requirements of analgesics</measure>
    <time_frame>At 0, 2, 4 and 24 hr</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Hip Arthroplasty</condition>
  <arm_group>
    <arm_group_label>Sevoflurane</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Desflurane</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sevoflurane</intervention_name>
    <description>Sevoflurane was used as a maintenance anesthetic agent.</description>
    <arm_group_label>Sevoflurane</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Desflurane</intervention_name>
    <description>Desflurane was used as a maintenance anesthetic agent.</description>
    <arm_group_label>Desflurane</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I-III&#xD;
&#xD;
          -  Patients scheduled for general anesthesia with endotracheal intubation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Difficult airway&#xD;
&#xD;
          -  Friable teeth&#xD;
&#xD;
          -  Rapid sequence induction&#xD;
&#xD;
          -  Recent sore throat&#xD;
&#xD;
          -  Recent upper respiratory infection&#xD;
&#xD;
          -  Asthma&#xD;
&#xD;
          -  Chronic obstructive pulmonary disease&#xD;
&#xD;
          -  Chronic cough&#xD;
&#xD;
          -  Arrhythmia&#xD;
&#xD;
          -  Coronary disease&#xD;
&#xD;
          -  Heart failure&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Allergy to sevoflurane&#xD;
&#xD;
          -  Allergy to desflurane&#xD;
&#xD;
          -  Fever after halogenated anesthetics&#xD;
&#xD;
          -  Jaundice after halogenated anesthetics&#xD;
&#xD;
          -  Malignant hyperthremia&#xD;
&#xD;
          -  Allergy to remifentanil&#xD;
&#xD;
          -  Friable teeth&#xD;
&#xD;
          -  History of head and neck surgery&#xD;
&#xD;
          -  Multiple intubation attempts&#xD;
&#xD;
          -  Regional anesthetic agents&#xD;
&#xD;
          -  Gastric tube&#xD;
&#xD;
          -  Dexamethasone&#xD;
&#xD;
          -  Severe hypovolemia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>August 21, 2017</last_update_submitted>
  <last_update_submitted_qc>August 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Keimyung University Dongsan Medical Center</investigator_affiliation>
    <investigator_full_name>Hyun-Chang Kim</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>intubation</keyword>
  <keyword>pharyngitis</keyword>
  <keyword>remifentanil</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>Sevoflurane</mesh_term>
    <mesh_term>Desflurane</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/NCT03259672
org study id: SevoDesPOST
nct id: NCT03259672
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This investigation is planned to compare the incidence and severity of postoperative sore
      throat according to the use of sevoflurane or desflurane.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Number of participants with postoperative sore throat
time frame: At 24 hr
measure: Number of participants with postoperative sore throat
time frame: At 0, 2, 4 and 24 hr
measure: Number of participants with postoperative hoarseness
time frame: At 0, 2, 4 and 24 hr
measure: Number of participants with postoperative cough
time frame: At 0, 2, 4 and 24 hr
measure: Number of participants with postoperative nausea
time frame: At 0, 2, 4 and 24 hr
measure: Number of participants with postoperative vomiting
time frame: At 0, 2, 4 and 24 hr
measure: Number of participants with additional pain medication
time frame: At 0, 2, 4 and 24 hr
measure: Visual analogue scale of postoperative pain
time frame: At 0, 2, 4 and 24 hr
measure: Number of participants with shivering
time frame: At 0, 2, 4 and 24 hr
measure: Requirements of analgesics
time frame: At 0, 2, 4 and 24 hr
arm group label: Sevoflurane
arm group type: Active Comparator
arm group label: Desflurane
arm group type: Experimental
intervention type: Drug
intervention name: Sevoflurane
description: Sevoflurane was used as a maintenance anesthetic agent.
arm group label: Sevoflurane
intervention type: Drug
intervention name: Desflurane
description: Desflurane was used as a maintenance anesthetic agent.
arm group label: Desflurane
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Keimyung University Dongsan Medical Center
investigator full name: Hyun-Chang Kim
investigator title: Assistant professor
mesh term: Pharyngitis
mesh term: Sevoflurane
mesh term: Desflurane