<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/NCT01715688</url>
  </required_header>
  <id_info>
    <org_study_id>NM2012-003</org_study_id>
    <nct_id>NCT01715688</nct_id>
  </id_info>
  <brief_title>Efficacy of Alkalinized Lidocaine in the Endotracheal Tube Cuff on the Incidence of Coughing During Emergence</brief_title>
  <official_title>Efficacy of Endotracheal Tube Cuffs Pre-filled With Alkalinized Lidocaine Compared to Endotracheal Tube Cuffs Filled With Saline on the Incidence of Coughing During Emergence of Anesthesia.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre hospitalier de l'Université de Montréal (CHUM)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre de Recherche du Centre Hospitalier de l'Université de Montréal</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre hospitalier de l'Université de Montréal (CHUM)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to compare the efficacy of endotracheal tube cuffs pre-filled with&#xD;
      alkalinized lidocaine on the:&#xD;
&#xD;
        -  incidence of coughing during emergence of general anesthesia&#xD;
&#xD;
        -  time needed for emergence following a desflurane-based anesthesia&#xD;
&#xD;
        -  incidence of sore throat after extubation.&#xD;
&#xD;
      The investigator's hypothesis is that the use of endotracheal tube cuffs pre-filled with&#xD;
      alkalinized lidocaine will reduce the incidence of coughing by 50% relative to a control&#xD;
      group following a desflurane-based anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Emergence is an important period of general anesthesia during which several problems can&#xD;
      occur. Coughing, hypertension, tachycardia and agitation have been observed during emergence&#xD;
      of general anesthesia.&#xD;
&#xD;
      Desflurane is a newer volatile agent allowing early recovery from anesthesia. This agent has&#xD;
      led to earlier discharge and more rapid resumption of normal activities after surgery.&#xD;
      However, an incidence of coughing around 70% has been reported after a desflurane-based&#xD;
      anesthesia. Different techniques and drugs have been studied to reduce coughing during&#xD;
      emergence.&#xD;
&#xD;
      Among others, the role of lidocaine given intravenously, topically, or intracuff has been&#xD;
      studied. Intracuff lidocaine has been shown to increase the tolerance to the endotracheal&#xD;
      tube without reducing the swallowing reflex. However, lidocaine slowly diffuses across the&#xD;
      tube's cuff. The addition of bicarbonates is required to increase its diffusion to the&#xD;
      underlying tracheal tissue. Alkalinization of lidocaine allows the diffusion of 65% of its&#xD;
      neutral base form over a period of 6 hours.&#xD;
&#xD;
      In vitro studies have demonstrated that the optimal time for local anesthetic diffusion&#xD;
      through the cuff may vary from 90 to 180 minutes. Due to its low onset, this technique would&#xD;
      be appropriate for long-duration surgeries. Pre-filling the endotracheal tube cuffs with&#xD;
      alkalinized lidocaine at least 90 minutes before intubation could be appropriate for&#xD;
      surgeries expected to last less than two hours.&#xD;
&#xD;
      This study will assess the efficacy of pre-filling endotracheal tube cuffs with alkalinized&#xD;
      lidocaine to prevent coughing during emergence in short-duration surgeries.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</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, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of coughing during emergence of general anesthesia</measure>
    <time_frame>At extubation (Day 0)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to emergence</measure>
    <time_frame>At extubation (Day 0)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of sore throat</measure>
    <time_frame>One hour after extubation (Day 0)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Cough</condition>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Alkalinized lidocaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The endotracheal tube cuff will be pre-filled at least 90 minutes before intubation with alkalinized lidocaine. Endotracheal tube cuff will be emptied before intubation and then re-filled with the same mixture following intubation to secure the position of the endotracheal tube. (cuff will be inflated until there is no air leak around the tube).&#xD;
During emergence, when the expired fraction of desflurane reaches 0.2 MAC, the patient will be asked to open his eyes every 30 seconds. Any coughing effort before 0.2 MAC will be considered as a treatment failure and the patient will be treated according to the attending anaesthesiologist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The endotracheal tube cuff will be pre-filled at least 90 minutes before intubation with saline. Endotracheal tube cuff will be emptied before intubation and then re-filled with the same mixture following intubation to secure the position of the endotracheal tube. (cuff will be inflated until there is no air leak around the tube).&#xD;
During emergence, when the expired fraction of desflurane reaches 0.2 MAC, the patient will be asked to open his eyes every 30 seconds. Any coughing effort before 0.2 MAC will be considered as a treatment failure and the patient will be treated according to the attending anaesthesiologist.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alkalinized lidocaine</intervention_name>
    <description>Administration of alkalinized lidocaine in the endotracheal tube cuff</description>
    <arm_group_label>Alkalinized lidocaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>Administration of saline in the endotracheal tube cuff</description>
    <arm_group_label>Saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing elective short-duration surgery under general anesthesia (expected&#xD;
             duration of less than 2 hours)&#xD;
&#xD;
          -  Physical status 1-3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Asthma or severe pulmonary disease&#xD;
&#xD;
          -  Pulmonary tract infection&#xD;
&#xD;
          -  Anticipated difficult intubation&#xD;
&#xD;
          -  Current use of cough medicine&#xD;
&#xD;
          -  Contraindication to lidocaine&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Airway surgery&#xD;
&#xD;
          -  Inability to provide informed consent&#xD;
&#xD;
          -  Patient refusal&#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>Nathalie Massicotte, MD, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier de l'Université de Monrtréal</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier de l'Université de Montréal</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2L 4M1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>January 28, 2016</last_update_submitted>
  <last_update_submitted_qc>January 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 1, 2016</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>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>
  <!-- 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/NCT01715688
org study id: NM2012-003
nct id: NCT01715688
lead sponsor: 
collaborator: 
has dmc: No
This study is designed to compare the efficacy of endotracheal tube cuffs pre-filled with
      alkalinized lidocaine on the:

        -  incidence of coughing during emergence of general anesthesia

        -  time needed for emergence following a desflurane-based anesthesia

        -  incidence of sore throat after extubation.

      The investigator's hypothesis is that the use of endotracheal tube cuffs pre-filled with
      alkalinized lidocaine will reduce the incidence of coughing by 50% relative to a control
      group following a desflurane-based anesthesia.
Emergence is an important period of general anesthesia during which several problems can
      occur. Coughing, hypertension, tachycardia and agitation have been observed during emergence
      of general anesthesia.

      Desflurane is a newer volatile agent allowing early recovery from anesthesia. This agent has
      led to earlier discharge and more rapid resumption of normal activities after surgery.
      However, an incidence of coughing around 70% has been reported after a desflurane-based
      anesthesia. Different techniques and drugs have been studied to reduce coughing during
      emergence.

      Among others, the role of lidocaine given intravenously, topically, or intracuff has been
      studied. Intracuff lidocaine has been shown to increase the tolerance to the endotracheal
      tube without reducing the swallowing reflex. However, lidocaine slowly diffuses across the
      tube's cuff. The addition of bicarbonates is required to increase its diffusion to the
      underlying tracheal tissue. Alkalinization of lidocaine allows the diffusion of 65% of its
      neutral base form over a period of 6 hours.

      In vitro studies have demonstrated that the optimal time for local anesthetic diffusion
      through the cuff may vary from 90 to 180 minutes. Due to its low onset, this technique would
      be appropriate for long-duration surgeries. Pre-filling the endotracheal tube cuffs with
      alkalinized lidocaine at least 90 minutes before intubation could be appropriate for
      surgeries expected to last less than two hours.

      This study will assess the efficacy of pre-filling endotracheal tube cuffs with alkalinized
      lidocaine to prevent coughing during emergence in short-duration surgeries.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Incidence of coughing during emergence of general anesthesia
time frame: At extubation (Day 0)
measure: Time to emergence
time frame: At extubation (Day 0)
measure: Incidence of sore throat
time frame: One hour after extubation (Day 0)
arm group label: Alkalinized lidocaine
arm group type: Active Comparator
description: The endotracheal tube cuff will be pre-filled at least 90 minutes before intubation with alkalinized lidocaine. Endotracheal tube cuff will be emptied before intubation and then re-filled with the same mixture following intubation to secure the position of the endotracheal tube. (cuff will be inflated until there is no air leak around the tube).
During emergence, when the expired fraction of desflurane reaches 0.2 MAC, the patient will be asked to open his eyes every 30 seconds. Any coughing effort before 0.2 MAC will be considered as a treatment failure and the patient will be treated according to the attending anaesthesiologist.
arm group label: Saline
arm group type: Placebo Comparator
description: The endotracheal tube cuff will be pre-filled at least 90 minutes before intubation with saline. Endotracheal tube cuff will be emptied before intubation and then re-filled with the same mixture following intubation to secure the position of the endotracheal tube. (cuff will be inflated until there is no air leak around the tube).
During emergence, when the expired fraction of desflurane reaches 0.2 MAC, the patient will be asked to open his eyes every 30 seconds. Any coughing effort before 0.2 MAC will be considered as a treatment failure and the patient will be treated according to the attending anaesthesiologist.
intervention type: Drug
intervention name: Alkalinized lidocaine
description: Administration of alkalinized lidocaine in the endotracheal tube cuff
arm group label: Alkalinized lidocaine
intervention type: Drug
intervention name: Saline
description: Administration of saline in the endotracheal tube cuff
arm group label: Saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nathalie Massicotte, MD, FRCPC
role: Principal Investigator
affiliation: Centre Hospitalier de l'Université de Monrtréal
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Cough
mesh term: Lidocaine