<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/NCT03779516</url>
  </required_header>
  <id_info>
    <org_study_id>AntalyaTRH 28</org_study_id>
    <nct_id>NCT03779516</nct_id>
  </id_info>
  <brief_title>Effect of Nebulized Lidocaine on Postoperative Sore Throat</brief_title>
  <official_title>Effect of Preoperative Nebulized Lidocaine on Postoperative Sore Throat After Endotracheal Intubation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Antalya Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Antalya Training and Research Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to test the hypothesis that use of preoperative nebulized&#xD;
      lidocaine is reduced the incidence of postoperative sore throat after endotracheal&#xD;
      intubation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adult patients undergoing video-assisted thoracic surgery (VATS) requiring double lumen tube&#xD;
      (DLT) endotracheal intubation for one-lung ventilation (OLV) were enrolled in the study.&#xD;
      Patients were randomized by means of computer-generated order randomization into two groups:&#xD;
      Group C (those who received a saline solution as placebo delivered by nebulization) and Group&#xD;
      L (those who received lidocaine delivered by nebulization).&#xD;
&#xD;
      At 1, 6 and 24 h after tracheal extubation, an observer blinded to treatments evaluated the&#xD;
      patients in terms of sore throat and hoarseness. In addition, Patients' satisfaction,&#xD;
      intraoperative and postoperative opioid and analgesics consumption and complaints such as&#xD;
      dysphagia, nausea and vomiting were recorded. Hemodynamic variables such as blood pressure&#xD;
      and heart rate were also recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    change in procedure&#xD;
  </why_stopped>
  <start_date type="Actual">December 19, 2018</start_date>
  <completion_date type="Actual">July 15, 2019</completion_date>
  <primary_completion_date type="Actual">April 22, 2019</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>Changes in the incidence of postoperative sore throat</measure>
    <time_frame>24 hours</time_frame>
    <description>Sore throat was assessed using a 0-100 mm visual analog scale (VAS), where a score of 0 represents no pain and a score of 100 reflects the worst pain imaginable.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>whether the hoarseness was present or not</measure>
    <time_frame>24 hours</time_frame>
    <description>Hoarseness was defined as a change in voice quality and it was assessed by the patients themselves. The change in voice quality at any time during the observation period was defined as &quot;hoarseness was present&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative opioid consumption</measure>
    <time_frame>60 minutes</time_frame>
    <description>Assessed in intraoperative period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative analgesic consumption</measure>
    <time_frame>24 hours</time_frame>
    <description>Assessed in postoperative period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in mean arterial pressure</measure>
    <time_frame>60 minutes</time_frame>
    <description>Assessed every 5 minutes during the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in heart rate</measure>
    <time_frame>60 minutes</time_frame>
    <description>Assessed every 5 minutes during the procedure</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Sore Throat</condition>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In Control Group, 4 mL of saline solution was administered using a face mask and a compressed gas-powered jet nebulizer for 15 min</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group L</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In Lidocaine Group 4 mL of 4% lidocaine was administered using a face mask and a compressed gas-powered jet nebulizer for 15 min</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>Effect of saline on postoperative sore throat</description>
    <arm_group_label>Group C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lidocaine</intervention_name>
    <description>Effect of nebulized lidocaine on postoperative sore throat</description>
    <arm_group_label>Group L</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients undergoing video-assisted thoracic surgery requiring double lumen tube&#xD;
             endotracheal intubation for one-lung ventilation&#xD;
&#xD;
          -  American Society of Anesthesiologists class 1,2 and 3&#xD;
&#xD;
          -  Ability to consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients &lt;18 years old&#xD;
&#xD;
          -  body mass index (BMI) &lt;20 or &gt;35 kg/m2&#xD;
&#xD;
          -  Mallampati grade 3 or 4&#xD;
&#xD;
          -  mouth opening &lt; 3 cm&#xD;
&#xD;
          -  preexisting hoarseness or sore throat&#xD;
&#xD;
          -  coagulopathy&#xD;
&#xD;
          -  patient with upper respiratory tract infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ali Sait Kavakli, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Antalya Training and Research Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hilal Yavuzel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ulku Arslan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karabuk University Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Antalya Training and Research Hospital</name>
      <address>
        <city>Antalya</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>April 28, 2020</last_update_submitted>
  <last_update_submitted_qc>April 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>Lidocaine</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/NCT03779516
org study id: AntalyaTRH 28
nct id: NCT03779516
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this study is to test the hypothesis that use of preoperative nebulized
      lidocaine is reduced the incidence of postoperative sore throat after endotracheal
      intubation.
Adult patients undergoing video-assisted thoracic surgery (VATS) requiring double lumen tube
      (DLT) endotracheal intubation for one-lung ventilation (OLV) were enrolled in the study.
      Patients were randomized by means of computer-generated order randomization into two groups:
      Group C (those who received a saline solution as placebo delivered by nebulization) and Group
      L (those who received lidocaine delivered by nebulization).

      At 1, 6 and 24 h after tracheal extubation, an observer blinded to treatments evaluated the
      patients in terms of sore throat and hoarseness. In addition, Patients' satisfaction,
      intraoperative and postoperative opioid and analgesics consumption and complaints such as
      dysphagia, nausea and vomiting were recorded. Hemodynamic variables such as blood pressure
      and heart rate were also recorded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Changes in the incidence of postoperative sore throat
time frame: 24 hours
description: Sore throat was assessed using a 0-100 mm visual analog scale (VAS), where a score of 0 represents no pain and a score of 100 reflects the worst pain imaginable.
measure: whether the hoarseness was present or not
time frame: 24 hours
description: Hoarseness was defined as a change in voice quality and it was assessed by the patients themselves. The change in voice quality at any time during the observation period was defined as "hoarseness was present".
measure: Intraoperative opioid consumption
time frame: 60 minutes
description: Assessed in intraoperative period
measure: Postoperative analgesic consumption
time frame: 24 hours
description: Assessed in postoperative period
measure: Changes in mean arterial pressure
time frame: 60 minutes
description: Assessed every 5 minutes during the procedure
measure: Changes in heart rate
time frame: 60 minutes
description: Assessed every 5 minutes during the procedure
arm group label: Group C
arm group type: Active Comparator
description: In Control Group, 4 mL of saline solution was administered using a face mask and a compressed gas-powered jet nebulizer for 15 min
arm group label: Group L
arm group type: Active Comparator
description: In Lidocaine Group 4 mL of 4% lidocaine was administered using a face mask and a compressed gas-powered jet nebulizer for 15 min
intervention type: Other
intervention name: Saline
description: Effect of saline on postoperative sore throat
arm group label: Group C
intervention type: Other
intervention name: Lidocaine
description: Effect of nebulized lidocaine on postoperative sore throat
arm group label: Group L
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ali Sait Kavakli, MD
role: Principal Investigator
affiliation: Antalya Training and Research Hospital
last name: Hilal Yavuzel, MD
role: Principal Investigator
affiliation: Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
last name: Ulku Arslan, MD
role: Principal Investigator
affiliation: Karabuk University Training and Research Hospital
facility: 
country: Turkey
responsible party type: Sponsor
mesh term: Pharyngitis
mesh term: Lidocaine