<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/NCT03805282</url>
  </required_header>
  <id_info>
    <org_study_id>LidoTosse</org_study_id>
    <nct_id>NCT03805282</nct_id>
  </id_info>
  <brief_title>Intravenous Lidocaine to Supress of Cough Reflex During Anesthesia Emergence</brief_title>
  <official_title>Intravenous Lidocaine Continuous-infusion to Supress of Cough Reflex During Anesthesia Emergence: Dose-finding Adaptive Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brasilia University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brasilia University 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Introduction: Although inflating tracheal cuff using lidocaine is effective for cough&#xD;
      suppression, it may pressure tracheal cuff too much. Intravenous continuous infusion of&#xD;
      lidocaine has emerged recently for most general anesthesia in the context of opioid-sparing&#xD;
      anesthesia for cancer, but the 95% effective dose (ED95) for cough suppression during&#xD;
      anesthesia emergence is not determined yet. Objective: the objectives of this study are to&#xD;
      determine the ED95 of continuous infusion lidocaine for suppressing cough reflex during&#xD;
      extubation by sex and age group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ideal patient weight in kg will be considered.&#xD;
&#xD;
      Initial dose will be 0.5mg/kg.h and dose-change steps of 0.5mg/kg.h will occur depending on&#xD;
      the incidence of emergence cough in the previous patient of the same group:&#xD;
&#xD;
        -  It will increase if coughed in a probability of 95%&#xD;
&#xD;
        -  It will decrease if not coughed in a probability of 5%.&#xD;
&#xD;
        -  It will remain the same otherwise. Maximum dose will be 3mg/kg.h. All patients will&#xD;
           receive remifentanil 0.025mcg/kg.min continuous infusion until extubation.&#xD;
&#xD;
      Patients groups will be determined by sex and age group (18-60 or &gt;60 years old), therefore,&#xD;
      four independent groups will be studied:&#xD;
&#xD;
        -  Female 18 to 60 years old&#xD;
&#xD;
        -  Male 18 to 60 years old&#xD;
&#xD;
        -  Female &gt; 60 years old&#xD;
&#xD;
        -  Male &gt; 60 years old&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 15, 2019</primary_completion_date>
  <phase>Phase 3</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>
    <intervention_model_description>Four parallel groups will be studied:&#xD;
Female &gt; 60 years old&#xD;
Male &gt; 60 years old&#xD;
Female 18 to 60 years old&#xD;
Male 18 to 60 years old</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>A study participant who will not participate during assessment of the main outcome will prepare the drug solutions to be infused at 10ml/h accordingly to the response of the previous patient and to the dose calculated for the next patient. The participant who will verify the main outcome during anesthesia emergence will not know the dose the patient is receiving. Participants will not be informed of the dose they will receive. The outcomes assessor will not handle individual data and statistical analysis plan was developed in advance.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Cough during anesthesia emergence</measure>
    <time_frame>Anytime during anesthesia emergence, before extubation.</time_frame>
    <description>Dichotomic variable, true if any cough is detected from anesthesia weaning to extubation.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">132</enrollment>
  <condition>Cough</condition>
  <arm_group>
    <arm_group_label>Female 18 to 60 years old</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This adaptive dose-finding group will receive continuous infusion lidocaine using the biased coin method for finding the 95% effective dose (ED95%) for cough suppression. All patients will also receive remifentanil 0.025mcg/kg.h during emergence.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Male 18 to 60 years old</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This adaptive dose-finding group will receive continuous infusion lidocaine using the biased coin method for finding the 95% effective dose (ED95%) for cough suppression. All patients will also receive remifentanil 0.025mcg/kg.h during emergence.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Male &gt; 60 years old</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This adaptive dose-finding group will receive continuous infusion lidocaine using the biased coin method for finding the 95% effective dose (ED95%) for cough suppression. All patients will also receive remifentanil 0.025mcg/kg.h during emergence.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Female &gt; 60 years old</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This adaptive dose-finding group will receive continuous infusion lidocaine using the biased coin method for finding the 95% effective dose (ED95%) for cough suppression. All patients will also receive remifentanil 0.025mcg/kg.h during emergence.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine</intervention_name>
    <description>Continuous infusion, variable dose of lidocaine.</description>
    <arm_group_label>Female 18 to 60 years old</arm_group_label>
    <arm_group_label>Female &gt; 60 years old</arm_group_label>
    <arm_group_label>Male 18 to 60 years old</arm_group_label>
    <arm_group_label>Male &gt; 60 years old</arm_group_label>
    <other_name>Xylocaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Understands study risks and benefits, signs informed consent.&#xD;
&#xD;
          -  Not pregnant.&#xD;
&#xD;
          -  Not an airway surgery&#xD;
&#xD;
          -  No acute or chronic respiratory disease.&#xD;
&#xD;
          -  Non smoker&#xD;
&#xD;
          -  No chronic cough&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any protocol violation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Gabriel MN Guimaraes, MSc</last_name>
    <phone>+55 61 996455997</phone>
    <email>gabrielmng@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital Universitario de Brasilia</name>
      <address>
        <city>Brasília</city>
        <state>Distrito Federal</state>
        <zip>70000000</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gabriel MN Guimaraes, MSc</last_name>
      <phone>+55 61 996455997</phone>
      <email>gabrielmng@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 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>Brasilia University Hospital</investigator_affiliation>
    <investigator_full_name>Gabriel Magalhaes Nunes Guimaraes</investigator_full_name>
    <investigator_title>Head of Anesthesiology</investigator_title>
  </responsible_party>
  <keyword>general anesthesia</keyword>
  <keyword>cough</keyword>
  <keyword>anesthesia emergence</keyword>
  <keyword>lidocaine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>we will make IPD available in www.anestesiologiaunb.com.br</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>In a year following the study</ipd_time_frame>
    <ipd_access_criteria>Open</ipd_access_criteria>
    <ipd_url>http://www.anestesiologiaunb.com.br</ipd_url>
  </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/NCT03805282
org study id: LidoTosse
nct id: NCT03805282
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Introduction: Although inflating tracheal cuff using lidocaine is effective for cough
      suppression, it may pressure tracheal cuff too much. Intravenous continuous infusion of
      lidocaine has emerged recently for most general anesthesia in the context of opioid-sparing
      anesthesia for cancer, but the 95% effective dose (ED95) for cough suppression during
      anesthesia emergence is not determined yet. Objective: the objectives of this study are to
      determine the ED95 of continuous infusion lidocaine for suppressing cough reflex during
      extubation by sex and age group.
Ideal patient weight in kg will be considered.

      Initial dose will be 0.5mg/kg.h and dose-change steps of 0.5mg/kg.h will occur depending on
      the incidence of emergence cough in the previous patient of the same group:

        -  It will increase if coughed in a probability of 95%

        -  It will decrease if not coughed in a probability of 5%.

        -  It will remain the same otherwise. Maximum dose will be 3mg/kg.h. All patients will
           receive remifentanil 0.025mcg/kg.min continuous infusion until extubation.

      Patients groups will be determined by sex and age group (18-60 or >60 years old), therefore,
      four independent groups will be studied:

        -  Female 18 to 60 years old

        -  Male 18 to 60 years old

        -  Female > 60 years old

        -  Male > 60 years old
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Four parallel groups will be studied:
Female > 60 years old
Male > 60 years old
Female 18 to 60 years old
Male 18 to 60 years old
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: A study participant who will not participate during assessment of the main outcome will prepare the drug solutions to be infused at 10ml/h accordingly to the response of the previous patient and to the dose calculated for the next patient. The participant who will verify the main outcome during anesthesia emergence will not know the dose the patient is receiving. Participants will not be informed of the dose they will receive. The outcomes assessor will not handle individual data and statistical analysis plan was developed in advance.
measure: Cough during anesthesia emergence
time frame: Anytime during anesthesia emergence, before extubation.
description: Dichotomic variable, true if any cough is detected from anesthesia weaning to extubation.
arm group label: Female 18 to 60 years old
arm group type: Experimental
description: This adaptive dose-finding group will receive continuous infusion lidocaine using the biased coin method for finding the 95% effective dose (ED95%) for cough suppression. All patients will also receive remifentanil 0.025mcg/kg.h during emergence.
arm group label: Male 18 to 60 years old
arm group type: Active Comparator
description: This adaptive dose-finding group will receive continuous infusion lidocaine using the biased coin method for finding the 95% effective dose (ED95%) for cough suppression. All patients will also receive remifentanil 0.025mcg/kg.h during emergence.
arm group label: Male > 60 years old
arm group type: Active Comparator
description: This adaptive dose-finding group will receive continuous infusion lidocaine using the biased coin method for finding the 95% effective dose (ED95%) for cough suppression. All patients will also receive remifentanil 0.025mcg/kg.h during emergence.
arm group label: Female > 60 years old
arm group type: Active Comparator
description: This adaptive dose-finding group will receive continuous infusion lidocaine using the biased coin method for finding the 95% effective dose (ED95%) for cough suppression. All patients will also receive remifentanil 0.025mcg/kg.h during emergence.
intervention type: Drug
intervention name: Lidocaine
description: Continuous infusion, variable dose of lidocaine.
arm group label: Female 18 to 60 years old
arm group label: Female > 60 years old
arm group label: Male 18 to 60 years old
arm group label: Male > 60 years old
other name: Xylocaine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 120 Years
healthy volunteers: No
last name: Gabriel MN Guimaraes, MSc
phone: +55 61 996455997
email: gabrielmng@gmail.com
facility: 
status: Recruiting
contact: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Brasilia University Hospital
investigator full name: Gabriel Magalhaes Nunes Guimaraes
investigator title: Head of Anesthesiology
mesh term: Cough
mesh term: Lidocaine
sharing ipd: Yes
ipd description: we will make IPD available in www.anestesiologiaunb.com.br
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: In a year following the study
ipd access criteria: Open
ipd url: http://www.anestesiologiaunb.com.br