<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/NCT03040193</url>
  </required_header>
  <id_info>
    <org_study_id>Ref.No.IEC-594/05.01.2017</org_study_id>
    <nct_id>NCT03040193</nct_id>
  </id_info>
  <brief_title>Nebulized Lignocaine for Topical Airway Anesthesia During Flexible Bronchoscopy: A Randomized Controlled Trial</brief_title>
  <acronym>NEBULA</acronym>
  <official_title>Nebulized Lignocaine for Topical Airway Anesthesia During Flexible Bronchoscopy: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>All India Institute of Medical Sciences, New Delhi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>All India Institute of Medical Sciences, New Delhi</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>
      Flexible bronchoscopy is one of the most widely performed procedures for diagnosis of various&#xD;
      bronchopulmonary diseases. Most patients tolerate the procedure well although cough is often&#xD;
      reported as a distressing symptom. It is likely that the acceptance of bronchoscopy would be&#xD;
      significantly improved with control of cough. Use of sedation during bronchoscopy has been&#xD;
      reported to improve procedure tolerance. However, awake(no sedation) bronchoscopy is&#xD;
      routinely performed at many centres including ours.&#xD;
&#xD;
      Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is&#xD;
      limited literature on the efficacy of lignocaine delivered with the nebulized route during&#xD;
      awake flexible bronchoscopy. This study would help to determine the utility of nebulized&#xD;
      lignocaine in airway anaesthesia during flexible bronchoscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For all patients meeting the inclusion criteria, the demographic profile including age, sex,&#xD;
      weight, smoking history and the type of procedures performed during bronchoscopy shall be&#xD;
      recorded. A written informed consent will be obtained from all participants. The patients who&#xD;
      undergo flexible bronchoscopy would be randomised in a one is to one ratio either to&#xD;
      nebulized lignocaine (4%) or saline (placebo) nebulization group. Prior to the bronchoscopy&#xD;
      blood pressure, pulse rate, respiratory rate and pulse oximetry saturation will be recorded&#xD;
      at the baseline Patients in both the groups shall be prepared in a similar fashion except for&#xD;
      the nebulized lignocaine. Patient, Operator, outcome assessor will be blinded to the&#xD;
      allocation.&#xD;
&#xD;
      During the procedure, 1.5ml aliquots of 1% lignocaine will be delivered through the&#xD;
      bronchoscope using spray-as-you go technique. The patients would be monitored for any adverse&#xD;
      effects throughout the procedure. The bronchoscopist doing the procedure will be provided 2&#xD;
      VAS charts to mark the severity of cough and overall procedure satisfaction.&#xD;
&#xD;
      Post procedure, patients will record the pain experienced while undergoing the procedure on&#xD;
      the faces pain rating scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2017</start_date>
  <completion_date type="Actual">December 15, 2017</completion_date>
  <primary_completion_date type="Actual">December 15, 2017</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>Diagnostic</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Operator rated overall procedure satisfaction VAS</measure>
    <time_frame>At study completion approx. 12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Operator rated cough VAS</measure>
    <time_frame>At study completion approx. 12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total dose of Lignocaine administered (mg)</measure>
    <time_frame>At study completion approx. 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients receiving dose &gt;8.2mg/Kg</measure>
    <time_frame>At study completion approx. 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Bronchopulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Nebulized Lignocaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4% Lignocaine administered as nebulization for topical anaesthesia during bronchoscopy procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nebulized Saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Normal Saline administered as nebulization for topical anaesthesia during bronchoscopy procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lignocaine Nebulization</intervention_name>
    <description>4% Lignocaine delivered via Nebulization</description>
    <arm_group_label>Nebulized Lignocaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline Nebulization</intervention_name>
    <description>Normal Saline Delivered via Nebulization</description>
    <arm_group_label>Nebulized Saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult (Age &gt; 18 years) patients undergoing diagnostic or therapeutic flexible&#xD;
             bronchoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy&#xD;
&#xD;
          2. Hypoxemia (oxygen saturation [by pulse oximetry] &lt; 92% with Fio2 of ≥ 0.3&#xD;
&#xD;
          3. Bronchoscopy done through endotracheal or tracheostomy tube&#xD;
&#xD;
          4. Not willing to provide informed consent.&#xD;
&#xD;
          5. Patient requiring sedation for flexible bronchoscopy&#xD;
&#xD;
          6. Patients with known allergy to lignocaine -&#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>Randeep Guleria, MD, DM</last_name>
    <role>Study Chair</role>
    <affiliation>AIIMS, New Delhi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>All India Institute of Medical Sciences</name>
      <address>
        <city>New Delhi</city>
        <zip>110029</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>January 28, 2018</last_update_submitted>
  <last_update_submitted_qc>January 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>All India Institute of Medical Sciences, New Delhi</investigator_affiliation>
    <investigator_full_name>Karan Madan</investigator_full_name>
    <investigator_title>Dr Karan Madan MD, DM Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Lignocaine</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03040193
org study id: Ref.No.IEC-594/05.01.2017
nct id: NCT03040193
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Flexible bronchoscopy is one of the most widely performed procedures for diagnosis of various
      bronchopulmonary diseases. Most patients tolerate the procedure well although cough is often
      reported as a distressing symptom. It is likely that the acceptance of bronchoscopy would be
      significantly improved with control of cough. Use of sedation during bronchoscopy has been
      reported to improve procedure tolerance. However, awake(no sedation) bronchoscopy is
      routinely performed at many centres including ours.

      Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is
      limited literature on the efficacy of lignocaine delivered with the nebulized route during
      awake flexible bronchoscopy. This study would help to determine the utility of nebulized
      lignocaine in airway anaesthesia during flexible bronchoscopy.
For all patients meeting the inclusion criteria, the demographic profile including age, sex,
      weight, smoking history and the type of procedures performed during bronchoscopy shall be
      recorded. A written informed consent will be obtained from all participants. The patients who
      undergo flexible bronchoscopy would be randomised in a one is to one ratio either to
      nebulized lignocaine (4%) or saline (placebo) nebulization group. Prior to the bronchoscopy
      blood pressure, pulse rate, respiratory rate and pulse oximetry saturation will be recorded
      at the baseline Patients in both the groups shall be prepared in a similar fashion except for
      the nebulized lignocaine. Patient, Operator, outcome assessor will be blinded to the
      allocation.

      During the procedure, 1.5ml aliquots of 1% lignocaine will be delivered through the
      bronchoscope using spray-as-you go technique. The patients would be monitored for any adverse
      effects throughout the procedure. The bronchoscopist doing the procedure will be provided 2
      VAS charts to mark the severity of cough and overall procedure satisfaction.

      Post procedure, patients will record the pain experienced while undergoing the procedure on
      the faces pain rating scale.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Operator rated overall procedure satisfaction VAS
time frame: At study completion approx. 12 months
measure: Operator rated cough VAS
time frame: At study completion approx. 12 months
measure: Total dose of Lignocaine administered (mg)
time frame: At study completion approx. 12 months
measure: Number of patients receiving dose >8.2mg/Kg
time frame: At study completion approx. 12 months
arm group label: Nebulized Lignocaine
arm group type: Experimental
description: 4% Lignocaine administered as nebulization for topical anaesthesia during bronchoscopy procedure
arm group label: Nebulized Saline
arm group type: Placebo Comparator
description: Normal Saline administered as nebulization for topical anaesthesia during bronchoscopy procedure
intervention type: Drug
intervention name: Lignocaine Nebulization
description: 4% Lignocaine delivered via Nebulization
arm group label: Nebulized Lignocaine
intervention type: Drug
intervention name: Saline Nebulization
description: Normal Saline Delivered via Nebulization
arm group label: Nebulized Saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Randeep Guleria, MD, DM
role: Study Chair
affiliation: AIIMS, New Delhi
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: All India Institute of Medical Sciences, New Delhi
investigator full name: Karan Madan
investigator title: Dr Karan Madan MD, DM Assistant Professor
mesh term: Lidocaine
sharing ipd: Undecided