<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/NCT01719978</url>
  </required_header>
  <id_info>
    <org_study_id>MTornelli</org_study_id>
    <nct_id>NCT01719978</nct_id>
  </id_info>
  <brief_title>Hemodynamic and Electrocardiographic Effects of Hyaluronidase Associated With Local Anaesthetics</brief_title>
  <official_title>Hemodynamic and Electrocardiographic Effects of Hyaluronidase Associated With Local Anaesthetics: a Double-blind &quot;Split-mouth&quot; Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mauricio Jose Tornelli</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Among the adjuvants to local anaesthetics (LA), the enzyme hyaluronidase is most often used&#xD;
      as a diffuser agent of the LA in ophthalmic anaesthesia. It serves to improve clinical&#xD;
      efficacy and prolong anaesthesia as an alternative to long-lasting and potentially more&#xD;
      dangerous LA, especially in patients with increased cardiovascular risk. There is scarce&#xD;
      clinical data about the safety of the use of hyaluronidase in dental procedures.&#xD;
&#xD;
      This study aimed to compare hemodynamic and electrocardiographic variables during a dental&#xD;
      surgical procedure using a local anaesthetic associated with hyaluronidase or placebo in&#xD;
      healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This double-blind crossover &quot;split-mouth&quot; trial evaluated the cardiovascular effects induced&#xD;
      by 3.6 mL of the LA 2% HCl mepivacaine with 1:100,000 epinephrine, concomitantly with 75&#xD;
      TRU/mL hyaluronidase or placebo in inferior alveolar nerve block, for the performance of&#xD;
      bilateral and symmetrical third molar surgery in 20 outpatients. Cardiovascular parameters,&#xD;
      including systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR),&#xD;
      were monitored using oscillometric and photoplethysmographic methods in 10 clinical stages.&#xD;
      Electrocardiographic records (ECG) of 12 leads were obtained in four steps. Hyaluronidase&#xD;
      injected concomitantly with LA did not induce changes in SBP, DBP and HR compared to placebo.&#xD;
      There were no instances of ST segment depression, ST segment elevation, wide QRS complex&#xD;
      extrasystoles, or narrow QRS complex extrasystoles.&#xD;
&#xD;
      To date, few studies in dentistry have investigated the effects of local anaesthetic efficacy&#xD;
      in hyaluronidase, and even fewer have studied the relation to systemic effects induced by&#xD;
      this interaction.&#xD;
&#xD;
      The use of LA injected concomitantly with 75 TRU/mL of hyaluronidase is safe when using this&#xD;
      dose and route of administration.&#xD;
&#xD;
      Clinical Relevance: In dentistry, few studies have investigated the effects of hyaluronidase&#xD;
      on local anaesthetic efficacy, and even fewer have examined the possible systemic effects&#xD;
      induced by this interaction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2007</start_date>
  <completion_date type="Actual">December 2011</completion_date>
  <primary_completion_date type="Actual">October 2007</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Arrhythmia</measure>
    <time_frame>5min before anaesthesia</time_frame>
    <description>Atrial or ventricular arrhythmias: isolated, paired or clustered extrasystoles, tachycardia, bradycardia and fibrillation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PR segment</measure>
    <time_frame>5min before anaesthesia; During anaesthetic injection; 5min after anaesthesia; Incision; Syndesmotomy; Luxation; Avulsion; Curetage; Suture; 1 hour after the end of surgery (At Patient discharge) and in the 7th postoperative day</time_frame>
    <description>• Duration of the PR segment, in milliseconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QRS complex</measure>
    <time_frame>5min before anaesthesia; During anaesthetic injection; 5min after anaesthesia; Incision; Syndesmotomy; Luxation; Avulsion; Curetage; Suture; 1 hour after the end of surgery (At Patient discharge) and in the 7th postoperative day</time_frame>
    <description>• Duration of the QRS complex, in milliseconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Heart rate</measure>
    <time_frame>5min before anaesthesia; During anaesthetic injection; 5min after anaesthesia; Incision; Syndesmotomy; Luxation; Avulsion; Curetage; Suture; 1 hour after the end of surgery (At Patient discharge) and in the 7th postoperative day</time_frame>
    <description>• Change from baseline Heart rate (evaluated period - baseline), in beats per minute. Values will be expressed as the absolute difference and the percentage of change.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Corrected QT</measure>
    <time_frame>5min before anaesthesia; During anaesthetic injection; 5min after anaesthesia; Incision; Syndesmotomy; Luxation; Avulsion; Curetage; Suture; 1 hour after the end of surgery (At Patient discharge) and in the 7th postoperative day</time_frame>
    <description>• Duration of the calculated corrected QT segment (QTc) in milliseconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate (absolute values)</measure>
    <time_frame>5min before anaesthesia; During anaesthetic injection; 5min after anaesthesia; Incision; Syndesmotomy; Luxation; Avulsion; Curetage; Suture; 1 hour after the end of surgery (At Patient discharge) and in the 7th postoperative day</time_frame>
    <description>• Heart rate, (absolute values) in beats per minute.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Systolic Pressure (absolute values)</measure>
    <time_frame>5min before anaesthesia; During anaesthetic injection; 5min after anaesthesia; Incision; Syndesmotomy; Luxation; Avulsion; Curetage; Suture; 1 hour after the end of surgery (At Patient discharge) and in the 7th postoperative day</time_frame>
    <description>Systolic Blood Pressure (absolute values), in mmHg.</description>
  </other_outcome>
  <other_outcome>
    <measure>Diastolic Pressure (absolute values)</measure>
    <time_frame>5min before anaesthesia; During anaesthetic injection; 5min after anaesthesia; Incision; Syndesmotomy; Luxation; Avulsion; Curetage; Suture; 1 hour after the end of surgery (At Patient discharge) and in the 7th postoperative day</time_frame>
    <description>Diastolic Blood Pressure, in mmHg.</description>
  </other_outcome>
  <other_outcome>
    <measure>Mean Blood Pressure (absolute values)</measure>
    <time_frame>5min before anaesthesia; During anaesthetic injection; 5min after anaesthesia; Incision; Syndesmotomy; Luxation; Avulsion; Curetage; Suture; 1 hour after the end of surgery (At Patient discharge) and in the 7th postoperative day</time_frame>
    <description>Mean Blood Pressure, in mmHg.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline Diastolic Pressure</measure>
    <time_frame>5min before anaesthesia; During anaesthetic injection; 5min after anaesthesia; Incision; Syndesmotomy; Luxation; Avulsion; Curetage; Suture; 1 hour after the end of surgery (At Patient discharge) and in the 7th postoperative day</time_frame>
    <description>• Change from baseline Diastolic Blood Pressure (evaluated period - baseline), in mmHg. Values will be expressed as the absolute difference and the percentage of change.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline Systolic Pressure</measure>
    <time_frame>5min before anaesthesia; During anaesthetic injection; 5min after anaesthesia; Incision; Syndesmotomy; Luxation; Avulsion; Curetage; Suture; 1 hour after the end of surgery (At Patient discharge) and in the 7th postoperative day</time_frame>
    <description>• Change from baseline Systolic Blood Pressure (evaluated period - baseline), in mmHg. Values will be expressed as the absolute difference and the percentage of change.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline Mean Arterial Blood Pressure</measure>
    <time_frame>5min before anaesthesia; During anaesthetic injection; 5min after anaesthesia; Incision; Syndesmotomy; Luxation; Avulsion; Curetage; Suture; 1 hour after the end of surgery (At Patient discharge) and in the 7th postoperative day</time_frame>
    <description>• Change from baseline Mean Arterial Blood Pressure (evaluated period - baseline), in mmHg. Values will be expressed as the absolute difference and the percentage of change.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Cardiac Arrhythmias</condition>
  <arm_group>
    <arm_group_label>Hyaluronidase</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lower Third Molar Extraction -- 3.6mL 2% Mepivacaine with 1:100,000 epinephrine + Hyaluronidase</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Lower Third Molar Extraction -- Anesthetic: 3.6 mL of the LA 2% HCl mepivacaine with 1:100,000 epinephrine + Placebo (0.9% saline)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>3.6mL 2% Mepivacaine with 1:100,000 epinephrine</intervention_name>
    <description>Local anesthetic with vasoconstrictor</description>
    <arm_group_label>Hyaluronidase</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Mepivacaine with epinephrine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Lower Third Molar Extraction</intervention_name>
    <description>Lower Third Molar Extraction with LA + hyaluronidase (or placebo)</description>
    <arm_group_label>Hyaluronidase</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Molar surgery</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hyaluronidase</intervention_name>
    <description>75RTU Hyaluronidase administration concomitant to the local anesthetic</description>
    <arm_group_label>Hyaluronidase</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>1mL 0.9% saline administration concomitant to the local anesthetic</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Saline</other_name>
    <other_name>0.9% NaCl</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients should present bilateral lower third molars (teeth 38 and 48) for extraction&#xD;
             and identical anatomical arrangement;&#xD;
&#xD;
          -  Absence of significant clinical morbidities, ASA I (American Society of&#xD;
             Anesthesiologists, 1963);&#xD;
&#xD;
          -  Aged over 18 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women during pregnancy or lactation;&#xD;
&#xD;
          -  Smokers;&#xD;
&#xD;
          -  History of sensitivity to any drug used in the research;&#xD;
&#xD;
          -  Presence or history of cancer or an infectious lesion;&#xD;
&#xD;
          -  Individuals who used any medication in the last 15 days (except oral contraceptives);&#xD;
&#xD;
          -  Presence of abscess or pericoronitis in the region to be operated;&#xD;
&#xD;
          -  Patients who required supplemental anaesthesia upon anaesthetic block of the inferior&#xD;
             alveolar nerve (post-randomisation exclusion).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gustavo F Prado, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>FMUSP</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maria A Borsatti, PhD</last_name>
    <role>Study Director</role>
    <affiliation>FOUSP</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rodney G Rocha, PhD</last_name>
    <role>Study Director</role>
    <affiliation>FOUSP</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Helena R Tornelli, MD, S</last_name>
    <role>Study Chair</role>
    <affiliation>FOUSP</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Renata MS Prado, MS, S</last_name>
    <role>Study Chair</role>
    <affiliation>FOUSP</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stomatology Department, FOUSP</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05508-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>October 31, 2012</last_update_submitted>
  <last_update_submitted_qc>October 31, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 2, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Mauricio Jose Tornelli</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Local Anaesthetics</keyword>
  <keyword>Mepivacaine</keyword>
  <keyword>hyaluronoglucosaminidase</keyword>
  <keyword>Hemodynamic</keyword>
  <keyword>Electrocardiography and Dentistry.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epinephrine</mesh_term>
    <mesh_term>Racepinephrine</mesh_term>
    <mesh_term>Mepivacaine</mesh_term>
    <mesh_term>Epinephryl borate</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01719978
org study id: MTornelli
nct id: NCT01719978
lead sponsor: 
collaborator: 
has dmc: No
Among the adjuvants to local anaesthetics (LA), the enzyme hyaluronidase is most often used
      as a diffuser agent of the LA in ophthalmic anaesthesia. It serves to improve clinical
      efficacy and prolong anaesthesia as an alternative to long-lasting and potentially more
      dangerous LA, especially in patients with increased cardiovascular risk. There is scarce
      clinical data about the safety of the use of hyaluronidase in dental procedures.

      This study aimed to compare hemodynamic and electrocardiographic variables during a dental
      surgical procedure using a local anaesthetic associated with hyaluronidase or placebo in
      healthy subjects.
This double-blind crossover "split-mouth" trial evaluated the cardiovascular effects induced
      by 3.6 mL of the LA 2% HCl mepivacaine with 1:100,000 epinephrine, concomitantly with 75
      TRU/mL hyaluronidase or placebo in inferior alveolar nerve block, for the performance of
      bilateral and symmetrical third molar surgery in 20 outpatients. Cardiovascular parameters,
      including systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR),
      were monitored using oscillometric and photoplethysmographic methods in 10 clinical stages.
      Electrocardiographic records (ECG) of 12 leads were obtained in four steps. Hyaluronidase
      injected concomitantly with LA did not induce changes in SBP, DBP and HR compared to placebo.
      There were no instances of ST segment depression, ST segment elevation, wide QRS complex
      extrasystoles, or narrow QRS complex extrasystoles.

      To date, few studies in dentistry have investigated the effects of local anaesthetic efficacy
      in hyaluronidase, and even fewer have studied the relation to systemic effects induced by
      this interaction.

      The use of LA injected concomitantly with 75 TRU/mL of hyaluronidase is safe when using this
      dose and route of administration.

      Clinical Relevance: In dentistry, few studies have investigated the effects of hyaluronidase
      on local anaesthetic efficacy, and even fewer have examined the possible systemic effects
      induced by this interaction.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Arrhythmia
time frame: 5min before anaesthesia
description: Atrial or ventricular arrhythmias: isolated, paired or clustered extrasystoles, tachycardia, bradycardia and fibrillation.
measure: PR segment
time frame: 5min before anaesthesia; During anaesthetic injection; 5min after anaesthesia; Incision; Syndesmotomy; Luxation; Avulsion; Curetage; Suture; 1 hour after the end of surgery (At Patient discharge) and in the 7th postoperative day
description: • Duration of the PR segment, in milliseconds.
measure: QRS complex
time frame: 5min before anaesthesia; During anaesthetic injection; 5min after anaesthesia; Incision; Syndesmotomy; Luxation; Avulsion; Curetage; Suture; 1 hour after the end of surgery (At Patient discharge) and in the 7th postoperative day
description: • Duration of the QRS complex, in milliseconds.
measure: Change from baseline Heart rate
time frame: 5min before anaesthesia; During anaesthetic injection; 5min after anaesthesia; Incision; Syndesmotomy; Luxation; Avulsion; Curetage; Suture; 1 hour after the end of surgery (At Patient discharge) and in the 7th postoperative day
description: • Change from baseline Heart rate (evaluated period - baseline), in beats per minute. Values will be expressed as the absolute difference and the percentage of change.
measure: Corrected QT
time frame: 5min before anaesthesia; During anaesthetic injection; 5min after anaesthesia; Incision; Syndesmotomy; Luxation; Avulsion; Curetage; Suture; 1 hour after the end of surgery (At Patient discharge) and in the 7th postoperative day
description: • Duration of the calculated corrected QT segment (QTc) in milliseconds.
measure: Heart rate (absolute values)
time frame: 5min before anaesthesia; During anaesthetic injection; 5min after anaesthesia; Incision; Syndesmotomy; Luxation; Avulsion; Curetage; Suture; 1 hour after the end of surgery (At Patient discharge) and in the 7th postoperative day
description: • Heart rate, (absolute values) in beats per minute.
measure: Systolic Pressure (absolute values)
time frame: 5min before anaesthesia; During anaesthetic injection; 5min after anaesthesia; Incision; Syndesmotomy; Luxation; Avulsion; Curetage; Suture; 1 hour after the end of surgery (At Patient discharge) and in the 7th postoperative day
description: Systolic Blood Pressure (absolute values), in mmHg.
measure: Diastolic Pressure (absolute values)
time frame: 5min before anaesthesia; During anaesthetic injection; 5min after anaesthesia; Incision; Syndesmotomy; Luxation; Avulsion; Curetage; Suture; 1 hour after the end of surgery (At Patient discharge) and in the 7th postoperative day
description: Diastolic Blood Pressure, in mmHg.
measure: Mean Blood Pressure (absolute values)
time frame: 5min before anaesthesia; During anaesthetic injection; 5min after anaesthesia; Incision; Syndesmotomy; Luxation; Avulsion; Curetage; Suture; 1 hour after the end of surgery (At Patient discharge) and in the 7th postoperative day
description: Mean Blood Pressure, in mmHg.
measure: Change from baseline Diastolic Pressure
time frame: 5min before anaesthesia; During anaesthetic injection; 5min after anaesthesia; Incision; Syndesmotomy; Luxation; Avulsion; Curetage; Suture; 1 hour after the end of surgery (At Patient discharge) and in the 7th postoperative day
description: • Change from baseline Diastolic Blood Pressure (evaluated period - baseline), in mmHg. Values will be expressed as the absolute difference and the percentage of change.
measure: Change from baseline Systolic Pressure
time frame: 5min before anaesthesia; During anaesthetic injection; 5min after anaesthesia; Incision; Syndesmotomy; Luxation; Avulsion; Curetage; Suture; 1 hour after the end of surgery (At Patient discharge) and in the 7th postoperative day
description: • Change from baseline Systolic Blood Pressure (evaluated period - baseline), in mmHg. Values will be expressed as the absolute difference and the percentage of change.
measure: Change from baseline Mean Arterial Blood Pressure
time frame: 5min before anaesthesia; During anaesthetic injection; 5min after anaesthesia; Incision; Syndesmotomy; Luxation; Avulsion; Curetage; Suture; 1 hour after the end of surgery (At Patient discharge) and in the 7th postoperative day
description: • Change from baseline Mean Arterial Blood Pressure (evaluated period - baseline), in mmHg. Values will be expressed as the absolute difference and the percentage of change.
arm group label: Hyaluronidase
arm group type: Active Comparator
description: Lower Third Molar Extraction -- 3.6mL 2% Mepivacaine with 1:100,000 epinephrine + Hyaluronidase
arm group label: Placebo
arm group type: Placebo Comparator
description: Lower Third Molar Extraction -- Anesthetic: 3.6 mL of the LA 2% HCl mepivacaine with 1:100,000 epinephrine + Placebo (0.9% saline)
intervention type: Drug
intervention name: 3.6mL 2% Mepivacaine with 1:100,000 epinephrine
description: Local anesthetic with vasoconstrictor
arm group label: Hyaluronidase
arm group label: Placebo
other name: Mepivacaine with epinephrine
intervention type: Procedure
intervention name: Lower Third Molar Extraction
description: Lower Third Molar Extraction with LA + hyaluronidase (or placebo)
arm group label: Hyaluronidase
arm group label: Placebo
other name: Molar surgery
intervention type: Drug
intervention name: Hyaluronidase
description: 75RTU Hyaluronidase administration concomitant to the local anesthetic
arm group label: Hyaluronidase
intervention type: Drug
intervention name: Placebo
description: 1mL 0.9% saline administration concomitant to the local anesthetic
arm group label: Placebo
other name: Saline
other name: 0.9% NaCl
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Gustavo F Prado, PhD
role: Study Chair
affiliation: FMUSP
last name: Maria A Borsatti, PhD
role: Study Director
affiliation: FOUSP
last name: Rodney G Rocha, PhD
role: Study Director
affiliation: FOUSP
last name: Helena R Tornelli, MD, S
role: Study Chair
affiliation: FOUSP
last name: Renata MS Prado, MS, S
role: Study Chair
affiliation: FOUSP
facility: 
country: Brazil
responsible party type: Sponsor-Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Mauricio Jose Tornelli
investigator title: PhD
mesh term: Arrhythmias, Cardiac
mesh term: Epinephrine
mesh term: Racepinephrine
mesh term: Mepivacaine
mesh term: Epinephryl borate