xml: <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/NCT06040034</url>
    </required_header>
    <id_info>
      <org_study_id>AN-202309.01</org_study_id>
      <nct_id>NCT06040034</nct_id>
    </id_info>
    <brief_title>Bolus vs. Continuous IV Lidocaine Against Post-Extubation Cough in Post-Thyroidectomy Patients</brief_title>
    <official_title>Comparison of Bolus Intravenous Lidocaine Administration With Continuous Intravenous Lidocaine Against Post-Extubation Cough Incidence in Post-Thyroidectomy Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universitas Padjadjaran</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universitas Padjadjaran</source>
    <oversight_info>
      <has_dmc>Yes</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>
        The goal of this randomized controlled trial is to compare the effect of lidocaine bolus&#xD;
        intravenous administration to lidocaine continuous intravenous administration in post&#xD;
        thyroidectomy patients to observe the effect against post-extubation cough. The main&#xD;
        questions it aims to answer are:&#xD;
  &#xD;
          -  Cough incidence on both groups&#xD;
  &#xD;
          -  Which method is preferable to reduce post-extubation cough incidence&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 2, 2023</start_date>
    <completion_date type="Actual">May 1, 2023</completion_date>
    <primary_completion_date type="Actual">May 1, 2023</primary_completion_date>
    <phase>Phase 2/Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Post-Extubation Cough</measure>
      <time_frame>24 hours post operative</time_frame>
      <description>Cough graded according to the following criteria:&#xD;
  Grade 0: no cough; Grade 1: mild, only 1 cough; Grade 2: moderate, &gt;1 cough lasting &lt;5 seconds; Grade 3: coughing heavily and continuously for &gt;5 seconds)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Nausea</measure>
      <time_frame>24 hours perioperative</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vomiting</measure>
      <time_frame>24 hours perioperative</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tachycardia</measure>
      <time_frame>24 hours perioperative</time_frame>
      <description>Heart rate &gt;100 beats per minute</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bradycardia</measure>
      <time_frame>24 hours perioperative</time_frame>
      <description>Heart rate &lt;60 beats per minute</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hypertension</measure>
      <time_frame>24 hours perioperative</time_frame>
      <description>Increase of blood pressure &gt;20% from initial blood pressure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hypotension</measure>
      <time_frame>24 hours perioperative</time_frame>
      <description>Decrease of blood pressure &lt;20% from initial blood pressure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Arhythmia</measure>
      <time_frame>24 hours perioperative</time_frame>
      <description>Heart rate disturbances</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">40</enrollment>
    <condition>Cough</condition>
    <arm_group>
      <arm_group_label>Continuous Lidocaine Intravenous Infusion</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients were given a loading dose of 1.5 mg/kgBW intravenous lidocaine for 10 minutes before induction of anesthesia using a syringe pump, followed by continuous intravenous administration of 1.5 mg/kgBW/hour lidocaine until 30 minutes before the end of the surgery (when the skin is being sutured by the surgeon) using a syringe pump. Continuous administration of lidocaine was prepared by the research team as 10 cc of 20 mg/cc lidocaine in a 10 cc syringe and 10 cc of 0.9% NaCl in a 10 cc syringe.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Bolus Lidocaine Intravenous</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients were given a loading dose of 1.5 mg/kgBW intravenous lidocaine for 10 minutes before induction of anesthesia using a syringe pump, followed by intravenous infusion of saline with the same volume until 30 minutes before the end of the surgery (when the skin is being sutured by the surgeon) using syringe pump.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Lidocaine IV</intervention_name>
      <description>Lidocaine given as bolus or continuous infusion.</description>
      <arm_group_label>Bolus Lidocaine Intravenous</arm_group_label>
      <arm_group_label>Continuous Lidocaine Intravenous Infusion</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ASA class 1 and 2&#xD;
  &#xD;
            -  Thyroidectomy patients in Hasan Sadikin Bandung Hospital&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subjects' refusal&#xD;
  &#xD;
            -  Had history of drug allergy, specifically lidaocaine&#xD;
  &#xD;
            -  Had history of asthma or other lung diseases&#xD;
  &#xD;
            -  Active smoker&#xD;
  &#xD;
            -  History of arrhythmia&#xD;
  &#xD;
            -  Bradycardia subjects (&lt;60 beats per minute)&#xD;
  &#xD;
            -  Pregnant people&#xD;
  &#xD;
            -  Perioperative upper respiratory tract infusion&#xD;
  &#xD;
            -  Routinely consume ACE inhibitor / bronchodilators / steroid&#xD;
  &#xD;
            -  Renal dysfunction&#xD;
  &#xD;
            -  Liver dysfunction&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Iwan Fuadi, MD</last_name>
      <role>Study Director</role>
      <affiliation>Faculty of Medicine Universitas Padjadjaran Bandung</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Ardi Zulfariansyah, MD</last_name>
      <role>Study Director</role>
      <affiliation>Faculty of Medicine Universitas Padjadjaran Bandung</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Hasan Sadikin General Hospital</name>
        <address>
          <city>Bandung</city>
          <state>West Java</state>
          <zip>40161</zip>
          <country>Indonesia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Indonesia</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 10, 2023</study_first_submitted>
    <study_first_submitted_qc>September 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 10, 2023</last_update_submitted>
    <last_update_submitted_qc>September 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</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>
  
  
text: 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/NCT06040034
  org study id: AN-202309.01
  nct id: NCT06040034
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this randomized controlled trial is to compare the effect of lidocaine bolus
        intravenous administration to lidocaine continuous intravenous administration in post
        thyroidectomy patients to observe the effect against post-extubation cough. The main
        questions it aims to answer are:
  
          -  Cough incidence on both groups
  
          -  Which method is preferable to reduce post-extubation cough incidence
  allocation: Randomized
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: Single (Care Provider)
  measure: Post-Extubation Cough
  time frame: 24 hours post operative
  description: Cough graded according to the following criteria:
  Grade 0: no cough; Grade 1: mild, only 1 cough; Grade 2: moderate, >1 cough lasting <5 seconds; Grade 3: coughing heavily and continuously for >5 seconds)
  measure: Nausea
  time frame: 24 hours perioperative
  measure: Vomiting
  time frame: 24 hours perioperative
  measure: Tachycardia
  time frame: 24 hours perioperative
  description: Heart rate >100 beats per minute
  measure: Bradycardia
  time frame: 24 hours perioperative
  description: Heart rate <60 beats per minute
  measure: Hypertension
  time frame: 24 hours perioperative
  description: Increase of blood pressure >20% from initial blood pressure
  measure: Hypotension
  time frame: 24 hours perioperative
  description: Decrease of blood pressure <20% from initial blood pressure
  measure: Arhythmia
  time frame: 24 hours perioperative
  description: Heart rate disturbances
  arm group label: Continuous Lidocaine Intravenous Infusion
  arm group type: Active Comparator
  description: Patients were given a loading dose of 1.5 mg/kgBW intravenous lidocaine for 10 minutes before induction of anesthesia using a syringe pump, followed by continuous intravenous administration of 1.5 mg/kgBW/hour lidocaine until 30 minutes before the end of the surgery (when the skin is being sutured by the surgeon) using a syringe pump. Continuous administration of lidocaine was prepared by the research team as 10 cc of 20 mg/cc lidocaine in a 10 cc syringe and 10 cc of 0.9% NaCl in a 10 cc syringe.
  arm group label: Bolus Lidocaine Intravenous
  arm group type: Active Comparator
  description: Patients were given a loading dose of 1.5 mg/kgBW intravenous lidocaine for 10 minutes before induction of anesthesia using a syringe pump, followed by intravenous infusion of saline with the same volume until 30 minutes before the end of the surgery (when the skin is being sutured by the surgeon) using syringe pump.
  intervention type: Drug
  intervention name: Lidocaine IV
  description: Lidocaine given as bolus or continuous infusion.
  arm group label: Bolus Lidocaine Intravenous
  arm group label: Continuous Lidocaine Intravenous Infusion
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: No
  last name: Iwan Fuadi, MD
  role: Study Director
  affiliation: Faculty of Medicine Universitas Padjadjaran Bandung
  last name: Ardi Zulfariansyah, MD
  role: Study Director
  affiliation: Faculty of Medicine Universitas Padjadjaran Bandung
  facility: 
  country: Indonesia
  responsible party type: Sponsor
  mesh term: Cough
  mesh term: Lidocaine