<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/NCT03787069</url>
  </required_header>
  <id_info>
    <org_study_id>IRD_IRB_2017_07_002</org_study_id>
    <nct_id>NCT03787069</nct_id>
  </id_info>
  <brief_title>Intravenous Lignocaine vs Placebo</brief_title>
  <official_title>Effect of Intravenous Lignocaine vs Placebo on Hemodynamic Response During Intubation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indus Hospital and Health Network</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indus Hospital and Health Network</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>
      To assess the mean hemodynamic responses post-intubation in patients given intravenous&#xD;
      lignocaine pre-intubation as compared to a placebo pre-intubation in patients undergoing&#xD;
      laryngoscopy surgery&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After identifying the candidate, details will be carefully discussed with the subject. The&#xD;
      subject (or, when necessary, the parent or legal guardian if the subject is younger than 18&#xD;
      years of age or under guardianship) will be read the approved protocol consent form. Patients&#xD;
      who have given informed consent to participate in the study will be randomized into one of&#xD;
      the two study arms one day before the procedure. The study team present will open the sealed&#xD;
      envelopes provided by the Indus Hospital Research Center's Clinical Research Unit (CRU) that&#xD;
      provides the study arm allocation. The envelopes will follow the SNOSE protocol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 20, 2017</start_date>
  <completion_date type="Actual">July 20, 2018</completion_date>
  <primary_completion_date type="Actual">July 20, 2018</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>Equal allocation</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>MAP</measure>
    <time_frame>post-intubation 3 minutes to 10 minutes</time_frame>
    <description>mean arterial pressure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pulse</measure>
    <time_frame>post-intubation 3 minutes to 10 minutes</time_frame>
    <description>Heart rate</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Hemodynamic Stability Post Intubation in Laryngoscopy Surgery</condition>
  <arm_group>
    <arm_group_label>Lignocaine group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will be given 1.5 mg/kg I/V lignocaine before intubation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This group will be given 6 ml normal saline before intubation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>iv Lignocaine vs placebo</intervention_name>
    <description>Lignocaine is available in an ampule of 10 ml containing 20 mg/ml of lignocaine or 2%, Lignocaine will be given in dose of 1.5 mg/kg I/V</description>
    <arm_group_label>Lignocaine group</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I and II&#xD;
&#xD;
          -  Age 20-60 years&#xD;
&#xD;
          -  Mallampatti , II&#xD;
&#xD;
          -  All surgeries are done under GA&#xD;
&#xD;
          -  Both genders&#xD;
&#xD;
          -  Those patients giving informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Difficult airway assessed during pre-op anaesthesia assessment&#xD;
&#xD;
          -  Unanticipated difficult airway based on the previous history of difficult intubation&#xD;
&#xD;
          -  BMI &gt;30,&#xD;
&#xD;
          -  Micrognathia and microglossia based on pre-op anaesthesia assessment,&#xD;
&#xD;
          -  Diabetic patient with autonomic dysfunction liver disease, cardiovascular disease,&#xD;
             pheochromocytoma, Cushing syndrome&#xD;
&#xD;
          -  Patients who do not give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Indus Hospital</name>
      <address>
        <city>Karachi</city>
        <state>Sind</state>
        <zip>75500</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 24, 2018</study_first_submitted>
  <study_first_submitted_qc>December 24, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>December 24, 2018</last_update_submitted>
  <last_update_submitted_qc>December 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03787069
org study id: IRD_IRB_2017_07_002
nct id: NCT03787069
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To assess the mean hemodynamic responses post-intubation in patients given intravenous
      lignocaine pre-intubation as compared to a placebo pre-intubation in patients undergoing
      laryngoscopy surgery
After identifying the candidate, details will be carefully discussed with the subject. The
      subject (or, when necessary, the parent or legal guardian if the subject is younger than 18
      years of age or under guardianship) will be read the approved protocol consent form. Patients
      who have given informed consent to participate in the study will be randomized into one of
      the two study arms one day before the procedure. The study team present will open the sealed
      envelopes provided by the Indus Hospital Research Center's Clinical Research Unit (CRU) that
      provides the study arm allocation. The envelopes will follow the SNOSE protocol.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Equal allocation
primary purpose: Prevention
masking: None (Open Label)
measure: MAP
time frame: post-intubation 3 minutes to 10 minutes
description: mean arterial pressure
measure: Pulse
time frame: post-intubation 3 minutes to 10 minutes
description: Heart rate
arm group label: Lignocaine group
arm group type: Experimental
description: This group will be given 1.5 mg/kg I/V lignocaine before intubation
arm group label: Placebo
arm group type: Placebo Comparator
description: This group will be given 6 ml normal saline before intubation
intervention type: Drug
intervention name: iv Lignocaine vs placebo
description: Lignocaine is available in an ampule of 10 ml containing 20 mg/ml of lignocaine or 2%, Lignocaine will be given in dose of 1.5 mg/kg I/V
arm group label: Lignocaine group
arm group label: Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Pakistan
responsible party type: Sponsor
mesh term: Lidocaine
sharing ipd: Undecided