<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/NCT03304431</url>
  </required_header>
  <id_info>
    <org_study_id>AbantIBU mb5</org_study_id>
    <nct_id>NCT03304431</nct_id>
  </id_info>
  <brief_title>Evaluation of the Effect of 10% Lidocaine Spray Undergoing Coronary Artery Bypass Graft Operation</brief_title>
  <acronym>ELCABG</acronym>
  <official_title>Evaluation of the Effect of 10% Lidocaine Spray on Hemodynamic Response and EKG Parameter Performed Before Endotracheal Intubation in Patients Undergoing Coronary Artery Bypass Graft Operation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abant Izzet Baysal University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abant Izzet Baysal University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      In patients undergoing coronary bypass surgery; 10% topical lidocaine administered&#xD;
      endotracheally before intubation is to investigate the effect of hemodynamic response and EKG&#xD;
      paramater after intubation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective randomized double-blind study consisted of 60 volunteers undergoing coronary&#xD;
      artery bypass surgery. Patients will be randomized and divided into two groups as control&#xD;
      (Group C) = 30) and topical lidocaine group (Group L) = 30). Two intravenous 18-gauge (G)&#xD;
      cannula will be inserted to all patients. Premedication will be provided with 0.03 mg/kg&#xD;
      intravenous (iv) midazolam (Dormicum 1 mg/ml, Roche preparations Inc., Istanbul Turkey) and&#xD;
      50 mcg fentanyl and patients will be given 2 L / min O2 via nasal cannula. Radial artery&#xD;
      cannulation will be performed by applying an Allen Test with 20G cannula under topical&#xD;
      anesthesia. heart rate (HR), mean arterial pressure (MAB), peripheral oxygen saturation&#xD;
      (SpO2) will be recorded. Induction of group C will be performed after preoperative&#xD;
      preparation. No intervention will be made in group c and standard anesthesia protocol will be&#xD;
      applied.&#xD;
&#xD;
      Group L (intervention group) Oral-tracheal lidocaine spray will be applied. The induction of&#xD;
      group L will be performed 5 minutes after administration of 10% topical lidocaine (Lidocaine&#xD;
      pump spray 10% 50 ml) 160 mg (16 puffs) . After pre-oxygenation, anesthesia induction will be&#xD;
      performed with intravenous administration of 2 μg / kg fentanyl, 2 mg/kg propofol, 0.6 mg/kg&#xD;
      rocuronium bromide (Esmeron 5 mg vial, Organon Oss Holanda). Tracheal intubation of all&#xD;
      patients will be performed by an experienced anesthesiologist after providing adequate&#xD;
      relaxation. Anesthesia will be maintained with sevoflurane(Forane, Abbott, İstanbul Türkiye)&#xD;
      % 2 in a 50% Air +50% O2 mixture. ECG recording of participants will be performed before&#xD;
      (baseline) and after one minute from induction and at the first and third minutes following&#xD;
      intubation. Hemodynamic measurements and record (MAB, HR, SpO2) will be performed at baseline&#xD;
      one minute after the induction of anesthesia as well as at 1,3,5,10 min after tracheal&#xD;
      intubation. Before the ECG analysis, all participants will be blinded by closing their group&#xD;
      names on the ECG recording. QTc (corrected QT,), QT intarvale dispersion (QTd), P wave&#xD;
      dispersion will calculated by a blind researcher within a 12-lead ECG recording (velocity: 25&#xD;
      mm / sec, Amplitude: 10 mm / mV). QTd , was the difference between the longest QT&#xD;
      intervale(QT max.) durations and shortest QT intervale(QT min.) durations(msec); P wave&#xD;
      dispersion, was the difference between the longest and shortest P-wave durations(msec); QTc&#xD;
      interval was calculated using Bazett's formula (QTc = QT/√RR).)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 26, 2017</start_date>
  <completion_date type="Actual">September 20, 2017</completion_date>
  <primary_completion_date type="Actual">August 20, 2017</primary_completion_date>
  <phase>Phase 4</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>The induction of group L will be performed 5 minutes after administration of 10% topical lidocaine (Vemcaine pump spray 10% 50 ml) 160 mg (16 puffs).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>QTc (corrected QT), QT dispersion (QTd), P wave dispersion will calculated by a blind researcher.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>ECG parameter</measure>
    <time_frame>baseline, one minute from induction,first and third minutes following intubation</time_frame>
    <description>P wave dispersion was the difference between the longest and shortest P-wave durations (msec); )</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>hemodynamic response</measure>
    <time_frame>baseline, after anesthesia induction one minute, after tracheal intubation 1 minute, 3 minute, 5 minute, 10 minute</time_frame>
    <description>heart rate (beats / minute)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hemodynamic response</measure>
    <time_frame>baseline, after anesthesia induction one minute, after tracheal intubation 1 minute,3 minute, 5 minute, 10 minute</time_frame>
    <description>mean arterial pressure(mmHg)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <condition>Lidocaine Causing Adverse Effects in Therapeutic Use</condition>
  <condition>Tracheal Intubation Morbidity</condition>
  <arm_group>
    <arm_group_label>Control group(Group C)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>After pre-oxygenation, anesthesia induction will be performed with intravenous administration of 2 μg / kg fentanyl, 2 mg/kg propofol, 0.6 mg/kg rocuronium bromide (Esmeron 5 mg vial, Organon Oss Holanda).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group L</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The induction of group L will be performed 5 minutes after administration of 10% topical lidocaine (Lidocaine pump spray 10% 50 ml) 160 mg (16 puffs) application</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Orotracheal Lidocaine Oral Spray application</intervention_name>
    <description>The induction of group L will be performed 5 minutes after administration of 10% topical lidocaine (Lidocaine pump spray 10% 50 ml) 160 mg (16 puffs) application</description>
    <arm_group_label>Group L</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  50-75 between age patients&#xD;
&#xD;
          -  ASA status III patients&#xD;
&#xD;
          -  patients undergoing coronary artery bypass graft operation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cardiomyopathy,&#xD;
&#xD;
          -  arrhythmia,&#xD;
&#xD;
          -  valvular disease,&#xD;
&#xD;
          -  electrolyte disorders&#xD;
&#xD;
          -  chronic liver and kidney diseases&#xD;
&#xD;
          -  use of medication that led to extended QT intervals&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>murat bilgi</last_name>
    <role>Principal Investigator</role>
    <affiliation>Abant Izzet Baysal University Medical School, Bolu, TURKEY</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Abant Izzet Baysal University Medical School,</name>
      <address>
        <city>Bolu</city>
        <zip>14280</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/?term=Effects+of+esmolol%2C+lidocaine+and+fentanyl+on+P+wave+dispersion%2C+QT%2C+QTc+intervals+and+hemodynamic+responses+to+endotracheal+intubation+during+propofol+induction%3A+a+comparative+study</url>
    <description>pubmed</description>
  </link>
  <results_reference>
    <citation>Hanci V, Yurtlu S, Karabag T, Okyay D, Hakimoglu S, Kayhan G, Buyukuysal C, Ayoglu H, Ozkocak Turan I. Effects of esmolol, lidocaine and fentanyl on P wave dispersion, QT, QTc intervals and hemodynamic responses to endotracheal intubation during propofol induction: a comparative study. Braz J Anesthesiol. 2013 May-Jun;63(3):235-44. doi: 10.1016/S0034-7094(13)70223-X. English, Portuguese, Spanish.</citation>
    <PMID>23683444</PMID>
  </results_reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>October 6, 2017</last_update_submitted>
  <last_update_submitted_qc>October 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>QT dispersion</keyword>
  <keyword>topical lidocaine</keyword>
  <keyword>P-wave values</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</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/NCT03304431
org study id: AbantIBU mb5
nct id: NCT03304431
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
In patients undergoing coronary bypass surgery; 10% topical lidocaine administered
      endotracheally before intubation is to investigate the effect of hemodynamic response and EKG
      paramater after intubation.
This prospective randomized double-blind study consisted of 60 volunteers undergoing coronary
      artery bypass surgery. Patients will be randomized and divided into two groups as control
      (Group C) = 30) and topical lidocaine group (Group L) = 30). Two intravenous 18-gauge (G)
      cannula will be inserted to all patients. Premedication will be provided with 0.03 mg/kg
      intravenous (iv) midazolam (Dormicum 1 mg/ml, Roche preparations Inc., Istanbul Turkey) and
      50 mcg fentanyl and patients will be given 2 L / min O2 via nasal cannula. Radial artery
      cannulation will be performed by applying an Allen Test with 20G cannula under topical
      anesthesia. heart rate (HR), mean arterial pressure (MAB), peripheral oxygen saturation
      (SpO2) will be recorded. Induction of group C will be performed after preoperative
      preparation. No intervention will be made in group c and standard anesthesia protocol will be
      applied.

      Group L (intervention group) Oral-tracheal lidocaine spray will be applied. The induction of
      group L will be performed 5 minutes after administration of 10% topical lidocaine (Lidocaine
      pump spray 10% 50 ml) 160 mg (16 puffs) . After pre-oxygenation, anesthesia induction will be
      performed with intravenous administration of 2 μg / kg fentanyl, 2 mg/kg propofol, 0.6 mg/kg
      rocuronium bromide (Esmeron 5 mg vial, Organon Oss Holanda). Tracheal intubation of all
      patients will be performed by an experienced anesthesiologist after providing adequate
      relaxation. Anesthesia will be maintained with sevoflurane(Forane, Abbott, İstanbul Türkiye)
      % 2 in a 50% Air +50% O2 mixture. ECG recording of participants will be performed before
      (baseline) and after one minute from induction and at the first and third minutes following
      intubation. Hemodynamic measurements and record (MAB, HR, SpO2) will be performed at baseline
      one minute after the induction of anesthesia as well as at 1,3,5,10 min after tracheal
      intubation. Before the ECG analysis, all participants will be blinded by closing their group
      names on the ECG recording. QTc (corrected QT,), QT intarvale dispersion (QTd), P wave
      dispersion will calculated by a blind researcher within a 12-lead ECG recording (velocity: 25
      mm / sec, Amplitude: 10 mm / mV). QTd , was the difference between the longest QT
      intervale(QT max.) durations and shortest QT intervale(QT min.) durations(msec); P wave
      dispersion, was the difference between the longest and shortest P-wave durations(msec); QTc
      interval was calculated using Bazett's formula (QTc = QT/√RR).)
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The induction of group L will be performed 5 minutes after administration of 10% topical lidocaine (Vemcaine pump spray 10% 50 ml) 160 mg (16 puffs).
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: QTc (corrected QT), QT dispersion (QTd), P wave dispersion will calculated by a blind researcher.
measure: ECG parameter
time frame: baseline, one minute from induction,first and third minutes following intubation
description: P wave dispersion was the difference between the longest and shortest P-wave durations (msec); )
measure: hemodynamic response
time frame: baseline, after anesthesia induction one minute, after tracheal intubation 1 minute, 3 minute, 5 minute, 10 minute
description: heart rate (beats / minute)
measure: hemodynamic response
time frame: baseline, after anesthesia induction one minute, after tracheal intubation 1 minute,3 minute, 5 minute, 10 minute
description: mean arterial pressure(mmHg)
arm group label: Control group(Group C)
arm group type: No Intervention
description: After pre-oxygenation, anesthesia induction will be performed with intravenous administration of 2 μg / kg fentanyl, 2 mg/kg propofol, 0.6 mg/kg rocuronium bromide (Esmeron 5 mg vial, Organon Oss Holanda).
arm group label: Group L
arm group type: Other
description: The induction of group L will be performed 5 minutes after administration of 10% topical lidocaine (Lidocaine pump spray 10% 50 ml) 160 mg (16 puffs) application
intervention type: Drug
intervention name: Orotracheal Lidocaine Oral Spray application
description: The induction of group L will be performed 5 minutes after administration of 10% topical lidocaine (Lidocaine pump spray 10% 50 ml) 160 mg (16 puffs) application
arm group label: Group L
criteria: 
gender: All
minimum age: 50 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: murat bilgi
role: Principal Investigator
affiliation: Abant Izzet Baysal University Medical School, Bolu, TURKEY
facility: 
country: Turkey
url: https://www.ncbi.nlm.nih.gov/pubmed/?term=Effects+of+esmolol%2C+lidocaine+and+fentanyl+on+P+wave+dispersion%2C+QT%2C+QTc+intervals+and+hemodynamic+responses+to+endotracheal+intubation+during+propofol+induction%3A+a+comparative+study
description: pubmed
citation: Hanci V, Yurtlu S, Karabag T, Okyay D, Hakimoglu S, Kayhan G, Buyukuysal C, Ayoglu H, Ozkocak Turan I. Effects of esmolol, lidocaine and fentanyl on P wave dispersion, QT, QTc intervals and hemodynamic responses to endotracheal intubation during propofol induction: a comparative study. Braz J Anesthesiol. 2013 May-Jun;63(3):235-44. doi: 10.1016/S0034-7094(13)70223-X. English, Portuguese, Spanish.
PMID: 23683444
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Lidocaine
sharing ipd: No