<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/NCT03792776</url>
  </required_header>
  <id_info>
    <org_study_id>CEHDF 1263</org_study_id>
    <nct_id>NCT03792776</nct_id>
  </id_info>
  <brief_title>Effect of Lidocaine 1% and 2% in the Tube Cuff on Postoperative Sore Throat and Cough</brief_title>
  <acronym>ELIT</acronym>
  <official_title>Effect of Lidocaine 1% and 2% in the Endotracheal Tube Cuff on Postoperative Sore Throat and Cough</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ogarite Habib</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Saint-Joseph University</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>
      Comparing the effect of different methods of endotracheal tube cuff inflation on the&#xD;
      occurrence of a postoperative sore throat and cough (Air vs Lidocaine 1% vs Lidocaine 2%).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligible patients undergoing general anesthesia will be randomized and assigned to three&#xD;
      groups:&#xD;
&#xD;
      Group A: Endotracheal tube cuff inflation with air Group B: Endotracheal tube cuff inflation&#xD;
      with Lidocaine 1% Group C: Endotracheal tube cuff inflation with Lidocaine 2%&#xD;
&#xD;
      The induction of anesthesia will be made following a preoxygenation with a facial mask with&#xD;
      100% Oxygen. It consists on the intravenous injection of Sufentanil 5 mcg or Fentanyl 50mcg,&#xD;
      Lidocaine 1mg/Kg, Propofol 2.5mg/kg, Rocuronium 0.6mg/kg or Cisatracurium 0.15mg/kg.&#xD;
&#xD;
      Maintenance of anesthesia will be done by sevoflurane + nitrous oxide, and reinjections of&#xD;
      morphinomimetics and curare will be made as needed (the total doses will be noted at the end&#xD;
      of the intervention).&#xD;
&#xD;
      The intubation is made by a N° 7.5 tube in men and a N° 7 tube in women. Cuff inflation will&#xD;
      be done upon placement of the endotracheal tube. The cuff's pressure will be monitored at&#xD;
      several intervals of the intervention and kept &lt; or = 20 centimeter of water (cmH2O).&#xD;
&#xD;
      The volume of lidocaine used will never exceed 5 mg / kg for the patient to be protected from&#xD;
      the local toxicity of the local anesthetic in case of accidental rupture of the balloon.&#xD;
&#xD;
      All patients will receive Paracetamol every 6 hours for the first 24 hours after the end of&#xD;
      surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2019</start_date>
  <completion_date type="Anticipated">October 2020</completion_date>
  <primary_completion_date type="Anticipated">April 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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sore throat intensity 0</measure>
    <time_frame>hour 0 after extubation</time_frame>
    <description>Throat pain evaluation using the visual analog scale of pain (range from 0 cm (no pain) to 10 cm (very intense pain))</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sore throat intensity 2</measure>
    <time_frame>at 2 hours after extubation</time_frame>
    <description>Throat pain evaluation using the visual analog scale of pain (range from 0 cm (no pain) to 10 cm (very intense pain))</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sore throat intensity 6</measure>
    <time_frame>at 6 hours after extubation</time_frame>
    <description>Throat pain evaluation using the visual analog scale of pain (range from 0 cm (no pain) to 10 cm (very intense pain))</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sore throat intensity 24</measure>
    <time_frame>at 24 hours after extubation</time_frame>
    <description>Throat pain evaluation using the visual analog scale of pain (range: from 0 cm (no pain) to 10 cm (very intense pain))</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cough intensity 0</measure>
    <time_frame>hour 0 after extubation</time_frame>
    <description>Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cough intensity 2</measure>
    <time_frame>at 2 hours after extubation</time_frame>
    <description>Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cough intensity 6</measure>
    <time_frame>at 6 hours after extubation</time_frame>
    <description>Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cough intensity 24</measure>
    <time_frame>at 24 hours after extubation</time_frame>
    <description>Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Postoperative Sore Throat</condition>
  <condition>Postoperative Cough</condition>
  <arm_group>
    <arm_group_label>Air</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Endotracheal tube cuff inflation with air</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lidocaine 1%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Endotracheal tube cuff inflation with Lidocaine 1%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lidocaine 2%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Endotracheal tube cuff inflation with Lidocaine 2%</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>cuff inflation with air</intervention_name>
    <description>Endotracheal tube cuff inflation with air</description>
    <arm_group_label>Air</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>cuff inflation with lidocaine 1%</intervention_name>
    <description>Endotracheal tube cuff inflation with lidocaine 1%</description>
    <arm_group_label>Lidocaine 1%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>cuff inflation with lidocaine 2%</intervention_name>
    <description>Endotracheal tube cuff inflation with lidocaine 2%</description>
    <arm_group_label>Lidocaine 2%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Induction of anesthesia</intervention_name>
    <description>The induction of anesthesia will be made following a preoxygenation with a facial mask with 100% Oxygen. It consists on the intravenous injection of Sufentanil 5 mcg or Fentanyl 50mcg, Lidocaine 1mg/Kg, Propofol 2.5mg/kg, Rocuronium 0.6mg/kg or Cisatracurium 0.15mg/kg.</description>
    <arm_group_label>Air</arm_group_label>
    <arm_group_label>Lidocaine 1%</arm_group_label>
    <arm_group_label>Lidocaine 2%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Maintenance of anesthesia</intervention_name>
    <description>Maintenance of anesthesia will be done by sevoflurane + nitrous oxide, and reinjections of morphinomimetics and curare will be made as needed (the total doses will be noted at the end of the intervention).</description>
    <arm_group_label>Air</arm_group_label>
    <arm_group_label>Lidocaine 1%</arm_group_label>
    <arm_group_label>Lidocaine 2%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Endotracheal intubation</intervention_name>
    <description>The intubation is made by a N° 7.5 tube in men and a N° 7 tube in women. Cuff inflation will be done upon placement of the endotracheal tube. The cuff's pressure will be monitored at several intervals of the intervention and kept &lt; or = 20 centimeter of water (cmH2O).</description>
    <arm_group_label>Air</arm_group_label>
    <arm_group_label>Lidocaine 1%</arm_group_label>
    <arm_group_label>Lidocaine 2%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Systematic post-operative analgesia</intervention_name>
    <description>All patients will receive Paracetamol every 6 hours for the first 24 hours after the end of surgery.</description>
    <arm_group_label>Air</arm_group_label>
    <arm_group_label>Lidocaine 1%</arm_group_label>
    <arm_group_label>Lidocaine 2%</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over 18 years old&#xD;
&#xD;
          -  American Society of Anesthesiologists classification (ASA) category 1 or 2&#xD;
&#xD;
          -  High pressure, low volume endotracheal tube - (Lo-pro)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ear nose and throat and cranial surgery&#xD;
&#xD;
          -  Ear nose and throat pathologies&#xD;
&#xD;
          -  Asthma and bronchial hyperreactivity&#xD;
&#xD;
          -  Chronic cough&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Cognitive disorders&#xD;
&#xD;
          -  Swallowing disorders&#xD;
&#xD;
          -  Corticotherapy during the last week&#xD;
&#xD;
          -  Allergy to lidocaine&#xD;
&#xD;
          -  Urgent surgery&#xD;
&#xD;
          -  Nasogastric, oro-gastric&#xD;
&#xD;
          -  Ventral position&#xD;
&#xD;
          -  More than 2 intubation attempts&#xD;
&#xD;
          -  Continuous intravenous infusion of lidocaine intraoperatively.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hicham Jabbour, MD</last_name>
    <role>Study Director</role>
    <affiliation>Saint JU</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ogarite P Habib, MD</last_name>
    <phone>+9613722518</phone>
    <email>Ogarite.habib@hotmail.com</email>
  </overall_contact>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 22, 2018</study_first_submitted>
  <study_first_submitted_qc>January 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>January 11, 2019</last_update_submitted>
  <last_update_submitted_qc>January 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Saint-Joseph University</investigator_affiliation>
    <investigator_full_name>Ogarite Habib</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Lidocaine 1%</keyword>
  <keyword>Lidocaine 2%</keyword>
  <keyword>Endotracheal tube cuff</keyword>
  <keyword>Cuff inflation</keyword>
  <keyword>Postoperative sore throat</keyword>
  <keyword>Postoperative cough</keyword>
  <keyword>General anesthesia</keyword>
  <keyword>Endotracheal intubation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pharyngitis</mesh_term>
    <mesh_term>Cough</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Anesthetics</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/NCT03792776
org study id: CEHDF 1263
nct id: NCT03792776
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Comparing the effect of different methods of endotracheal tube cuff inflation on the
      occurrence of a postoperative sore throat and cough (Air vs Lidocaine 1% vs Lidocaine 2%).
Eligible patients undergoing general anesthesia will be randomized and assigned to three
      groups:

      Group A: Endotracheal tube cuff inflation with air Group B: Endotracheal tube cuff inflation
      with Lidocaine 1% Group C: Endotracheal tube cuff inflation with Lidocaine 2%

      The induction of anesthesia will be made following a preoxygenation with a facial mask with
      100% Oxygen. It consists on the intravenous injection of Sufentanil 5 mcg or Fentanyl 50mcg,
      Lidocaine 1mg/Kg, Propofol 2.5mg/kg, Rocuronium 0.6mg/kg or Cisatracurium 0.15mg/kg.

      Maintenance of anesthesia will be done by sevoflurane + nitrous oxide, and reinjections of
      morphinomimetics and curare will be made as needed (the total doses will be noted at the end
      of the intervention).

      The intubation is made by a N° 7.5 tube in men and a N° 7 tube in women. Cuff inflation will
      be done upon placement of the endotracheal tube. The cuff's pressure will be monitored at
      several intervals of the intervention and kept < or = 20 centimeter of water (cmH2O).

      The volume of lidocaine used will never exceed 5 mg / kg for the patient to be protected from
      the local toxicity of the local anesthetic in case of accidental rupture of the balloon.

      All patients will receive Paracetamol every 6 hours for the first 24 hours after the end of
      surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Sore throat intensity 0
time frame: hour 0 after extubation
description: Throat pain evaluation using the visual analog scale of pain (range from 0 cm (no pain) to 10 cm (very intense pain))
measure: Sore throat intensity 2
time frame: at 2 hours after extubation
description: Throat pain evaluation using the visual analog scale of pain (range from 0 cm (no pain) to 10 cm (very intense pain))
measure: Sore throat intensity 6
time frame: at 6 hours after extubation
description: Throat pain evaluation using the visual analog scale of pain (range from 0 cm (no pain) to 10 cm (very intense pain))
measure: Sore throat intensity 24
time frame: at 24 hours after extubation
description: Throat pain evaluation using the visual analog scale of pain (range: from 0 cm (no pain) to 10 cm (very intense pain))
measure: Cough intensity 0
time frame: hour 0 after extubation
description: Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))
measure: Cough intensity 2
time frame: at 2 hours after extubation
description: Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))
measure: Cough intensity 6
time frame: at 6 hours after extubation
description: Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))
measure: Cough intensity 24
time frame: at 24 hours after extubation
description: Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))
arm group label: Air
arm group type: Active Comparator
description: Endotracheal tube cuff inflation with air
arm group label: Lidocaine 1%
arm group type: Experimental
description: Endotracheal tube cuff inflation with Lidocaine 1%
arm group label: Lidocaine 2%
arm group type: Experimental
description: Endotracheal tube cuff inflation with Lidocaine 2%
intervention type: Other
intervention name: cuff inflation with air
description: Endotracheal tube cuff inflation with air
arm group label: Air
intervention type: Drug
intervention name: cuff inflation with lidocaine 1%
description: Endotracheal tube cuff inflation with lidocaine 1%
arm group label: Lidocaine 1%
intervention type: Drug
intervention name: cuff inflation with lidocaine 2%
description: Endotracheal tube cuff inflation with lidocaine 2%
arm group label: Lidocaine 2%
intervention type: Other
intervention name: Induction of anesthesia
description: The induction of anesthesia will be made following a preoxygenation with a facial mask with 100% Oxygen. It consists on the intravenous injection of Sufentanil 5 mcg or Fentanyl 50mcg, Lidocaine 1mg/Kg, Propofol 2.5mg/kg, Rocuronium 0.6mg/kg or Cisatracurium 0.15mg/kg.
arm group label: Air
arm group label: Lidocaine 1%
arm group label: Lidocaine 2%
intervention type: Other
intervention name: Maintenance of anesthesia
description: Maintenance of anesthesia will be done by sevoflurane + nitrous oxide, and reinjections of morphinomimetics and curare will be made as needed (the total doses will be noted at the end of the intervention).
arm group label: Air
arm group label: Lidocaine 1%
arm group label: Lidocaine 2%
intervention type: Other
intervention name: Endotracheal intubation
description: The intubation is made by a N° 7.5 tube in men and a N° 7 tube in women. Cuff inflation will be done upon placement of the endotracheal tube. The cuff's pressure will be monitored at several intervals of the intervention and kept < or = 20 centimeter of water (cmH2O).
arm group label: Air
arm group label: Lidocaine 1%
arm group label: Lidocaine 2%
intervention type: Other
intervention name: Systematic post-operative analgesia
description: All patients will receive Paracetamol every 6 hours for the first 24 hours after the end of surgery.
arm group label: Air
arm group label: Lidocaine 1%
arm group label: Lidocaine 2%
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hicham Jabbour, MD
role: Study Director
affiliation: Saint JU
last name: Ogarite P Habib, MD
phone: +9613722518
email: Ogarite.habib@hotmail.com
responsible party type: Sponsor-Investigator
investigator affiliation: Saint-Joseph University
investigator full name: Ogarite Habib
investigator title: Principal Investigator
mesh term: Pharyngitis
mesh term: Cough
mesh term: Lidocaine
mesh term: Anesthetics