<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/NCT04455711</url>
  </required_header>
  <id_info>
    <org_study_id>AJIRB-MED-OBS-16-342</org_study_id>
    <nct_id>NCT04455711</nct_id>
  </id_info>
  <brief_title>The Effect of Lidocaine on Smooth Emergence With Double Lumen Tube</brief_title>
  <official_title>The Efficacy of Intravenous Lidocaine With Continuous Infusion of Remifentanil for Attenuating Double Lumen Tube Induced Cough During Emergence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ajou University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ajou University School of Medicine</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cough suppression during emergence and tracheal extubation from general anaesthesia has&#xD;
      become an important issue as part of patient safety. Cough arised from the mechanical&#xD;
      irritation of endotracheal tube and cuff could be accompanied by various adverse effects such&#xD;
      as laryngospasm, hypertension, tachycardia, arrhythmia and increase of intracranial,&#xD;
      intraocular, or intra-abdominal pressure.&#xD;
&#xD;
      Several cough-preventing strategies have been proposed for smooth emergence, such as opioids,&#xD;
      dexmedetomidine or lidocaine. Maintenance of remifentanil infusion during emergence has been&#xD;
      reported to be an effective method in reducing cough and cardiovascular change without delay&#xD;
      of recovery. In previous studies, the effetive effect-site concentraions for 95% of adults&#xD;
      (EC95) for preventing cough are a little different depending on anaestheic agent, type of&#xD;
      surgery and sex, ranged from 2.14 to 2.94 ng/ml. However, since most of these studies are for&#xD;
      sing lumen endotracheal tube, similar preventing effect would not be expected for double&#xD;
      lumen tube (DLT) because of its large diameter and long length. Another problem is higher&#xD;
      concentration of remifentanil more than 2.5 ng/ml could not guarantee the safety after&#xD;
      extubation. The efficacy of a single IV bolus of lidocaine for the prevention of cough has&#xD;
      been the subject of numerous trials.&#xD;
&#xD;
      Therefore, combined use of lidocaine and remifentanil could effectively prevent emergence&#xD;
      cough for DLT without the risk of high concentration of remifentanil.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">July 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2021</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>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cough incidence</measure>
    <time_frame>from the time of end of the operation up to 10 min after extubation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cough severity</measure>
    <time_frame>from the time of end of the operation up to 10 min after extubation</time_frame>
    <description>cough severity is graded as follows; mild cough (1 cough without lifting head), moderate cough ( more than 1 cough not sustained more than 5 seconds), severe cough (cough sustained more than 5 seconds)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hoarseness</measure>
    <time_frame>30 min at the recovery room</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Cough</condition>
  <condition>Lidocaine</condition>
  <arm_group>
    <arm_group_label>Remifentanil group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Emerge with continuous infusion of remifentanil 1.5 ng/ml</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lidocaine group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Emerge with continuous infusion of remifentanil 1.5 ng/ml with IV bolus of lidocaine 1.5 mg/kg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine Iv</intervention_name>
    <description>Bolus dose of 1.5 mg/kg lidocaine was injected immediate after operation.</description>
    <arm_group_label>Lidocaine group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Remifentanil</intervention_name>
    <description>Continuous infusion of remifentanil 1.5 ng/ml until extubation</description>
    <arm_group_label>Lidocaine group</arm_group_label>
    <arm_group_label>Remifentanil group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients needs for double lumen tube intubation for one lung ventilation during&#xD;
             surgery with ASA (American society of Anesthesiologists) class I or II&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Gastroesophageal reflux disease&#xD;
&#xD;
          -  Obese patients (BMI &gt; 30)&#xD;
&#xD;
          -  Recent upper respiratory infection history (within 3 weeks)&#xD;
&#xD;
          -  Asthma history&#xD;
&#xD;
          -  Anticipating difficult airway&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ji young Yoo</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ajou University School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ji young Yoo, assistant professor</last_name>
    <phone>82-31-219-5577</phone>
    <email>springbear@nate.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ajou University Hospital</name>
      <address>
        <city>Suwon</city>
        <state>Gyeonggido</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <contact>
      <last_name>Jiyoung Yoo, assistant professor</last_name>
      <phone>031-219-5577</phone>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>June 29, 2020</last_update_submitted>
  <last_update_submitted_qc>June 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ajou University School of Medicine</investigator_affiliation>
    <investigator_full_name>Jiyoung Yoo</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </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>
    <mesh_term>Remifentanil</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04455711
org study id: AJIRB-MED-OBS-16-342
nct id: NCT04455711
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Cough suppression during emergence and tracheal extubation from general anaesthesia has
      become an important issue as part of patient safety. Cough arised from the mechanical
      irritation of endotracheal tube and cuff could be accompanied by various adverse effects such
      as laryngospasm, hypertension, tachycardia, arrhythmia and increase of intracranial,
      intraocular, or intra-abdominal pressure.

      Several cough-preventing strategies have been proposed for smooth emergence, such as opioids,
      dexmedetomidine or lidocaine. Maintenance of remifentanil infusion during emergence has been
      reported to be an effective method in reducing cough and cardiovascular change without delay
      of recovery. In previous studies, the effetive effect-site concentraions for 95% of adults
      (EC95) for preventing cough are a little different depending on anaestheic agent, type of
      surgery and sex, ranged from 2.14 to 2.94 ng/ml. However, since most of these studies are for
      sing lumen endotracheal tube, similar preventing effect would not be expected for double
      lumen tube (DLT) because of its large diameter and long length. Another problem is higher
      concentration of remifentanil more than 2.5 ng/ml could not guarantee the safety after
      extubation. The efficacy of a single IV bolus of lidocaine for the prevention of cough has
      been the subject of numerous trials.

      Therefore, combined use of lidocaine and remifentanil could effectively prevent emergence
      cough for DLT without the risk of high concentration of remifentanil.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: Cough incidence
time frame: from the time of end of the operation up to 10 min after extubation
measure: Cough severity
time frame: from the time of end of the operation up to 10 min after extubation
description: cough severity is graded as follows; mild cough (1 cough without lifting head), moderate cough ( more than 1 cough not sustained more than 5 seconds), severe cough (cough sustained more than 5 seconds)
measure: hoarseness
time frame: 30 min at the recovery room
arm group label: Remifentanil group
arm group type: Placebo Comparator
description: Emerge with continuous infusion of remifentanil 1.5 ng/ml
arm group label: Lidocaine group
arm group type: Experimental
description: Emerge with continuous infusion of remifentanil 1.5 ng/ml with IV bolus of lidocaine 1.5 mg/kg
intervention type: Drug
intervention name: Lidocaine Iv
description: Bolus dose of 1.5 mg/kg lidocaine was injected immediate after operation.
arm group label: Lidocaine group
intervention type: Drug
intervention name: Remifentanil
description: Continuous infusion of remifentanil 1.5 ng/ml until extubation
arm group label: Lidocaine group
arm group label: Remifentanil group
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ji young Yoo
role: Principal Investigator
affiliation: Ajou University School of Medicine
last name: Ji young Yoo, assistant professor
phone: 82-31-219-5577
email: springbear@nate.com
facility: 
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Ajou University School of Medicine
investigator full name: Jiyoung Yoo
investigator title: Assistant professor
mesh term: Cough
mesh term: Lidocaine
mesh term: Remifentanil
sharing ipd: No