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Safety of Local Dental Anesthesia in Patients With Cardiac Channelopathies (SLDAPCC)

Primary Purpose

Channelopathies, Brugada Syndrome, Long QT Syndrome

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Dental restorative procedure
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Channelopathies focused on measuring arrhythmias, cardiac, channelopathies, death, sudden, genetic testing, electrocardiography, ambulatory, anesthesia, local, dentistry

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with any channelopathies below, kept on optimal drug therapy, with or without ICD:

Brugada Syndrome, Long QT Syndrome and Catecholaminergic Polymorphic Ventricular Tachycardia

  • Dental caries or unsatisfactory restorations in the mandible, indicating restorative dental treatment

Exclusion Criteria:

  • Patients allergic to lidocaine
  • Patients undergoing ICD therapy for less than three months
  • Patients with recurrent syncope in the last three months
  • Patients with sustained arrhythmias documented for less than 3 months
  • Have received epinephrine in the last 24 hours

Sites / Locations

  • Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Lidocaine with epinephrine

Lidocaine

Arm Description

Application of local dental anesthesia with two cartridges (3,6 mL) of lidocaine 2% with epinephrine 1:100.000 for dental restorative procedures in patients with cardiac channelopathies.

Application of local dental anesthesia with two cartridges (3,6 mL) of lidocaine 2% without vasoconstrictor for dental restorative procedures in patients with cardiac channelopathies.

Outcomes

Primary Outcome Measures

No sustained ventricular tachycardia
No life-threatening arrhythmias and clinical signs and symptoms

Secondary Outcome Measures

Full Information

First Posted
October 15, 2015
Last Updated
November 20, 2018
Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03182777
Brief Title
Safety of Local Dental Anesthesia in Patients With Cardiac Channelopathies
Acronym
SLDAPCC
Official Title
Safety of Local Dental Anesthesia in Patients With Cardiac Channelopathies
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Patients with cardiac channelopathies needing restorative dental treatment will be included in two sessions of the study, using local dental anesthetic: lidocaine 2% with epinephrine and lidocaine 2% without vasoconstrictor. The safety of the use of two cartridges (3.6 mL) will be evaluated. The patients will be their own control and will be assessed by Holter monitoring for 28 hours, blood pressure measurement and anxiety measuring.
Detailed Description
Patients of Heart Institute of the University of São Paulo with inherited cardiac channelopathies will be included, considering the criteria for inclusion and non-inclusion, after reading and signing the informed consent. They will undergo dental restorative treatment in two sessions, in the morning period, with an interval of at least seven days (wash-out) between them, and the patients will be their own control. In the first session, after randomization, patients will receive lidocaine 2% without vasoconstrictor (LSA) or lidocaine 2% with 1: 100,000 epinephrine (LCA) (cross-over), resulting in two conditions: with adrenaline and without adrenaline. The randomization of the anesthetic solution will be performed by the main researcher, being blind to the performer researcher and to the patient. The injected volume will be 3.6 mL (2 cartridges) of the anesthetic solution, using blocking technique of the inferior alveolar nerve. The patients will be monitored by Holter for 28 hours starting one hour before the procedure, for registration and analysis of cardiac electrical activity during the two sessions. Blood pressure will be monitored with digital sphygmomanometer and anxiety will be measured with Facial Image Scale, both on three occasions: at the beginning of the baseline periods, before starting application of anesthesia and at the end of the proceedings. The results will be analyzed statistically.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Channelopathies, Brugada Syndrome, Long QT Syndrome, Ventricular, Tachycardia
Keywords
arrhythmias, cardiac, channelopathies, death, sudden, genetic testing, electrocardiography, ambulatory, anesthesia, local, dentistry

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine with epinephrine
Arm Type
Active Comparator
Arm Description
Application of local dental anesthesia with two cartridges (3,6 mL) of lidocaine 2% with epinephrine 1:100.000 for dental restorative procedures in patients with cardiac channelopathies.
Arm Title
Lidocaine
Arm Type
Active Comparator
Arm Description
Application of local dental anesthesia with two cartridges (3,6 mL) of lidocaine 2% without vasoconstrictor for dental restorative procedures in patients with cardiac channelopathies.
Intervention Type
Procedure
Intervention Name(s)
Dental restorative procedure
Intervention Description
Infiltration of two cartridges (3.6 mL) of local anesthetics with 2% lidocaine with or without epinephrine 1:100,000, in two sessions with an interval of seven days between them, in oral mucosa in patients with cardiac channelopathies.
Primary Outcome Measure Information:
Title
No sustained ventricular tachycardia
Description
No life-threatening arrhythmias and clinical signs and symptoms
Time Frame
during dental procedures

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with any channelopathies below, kept on optimal drug therapy, with or without ICD: Brugada Syndrome, Long QT Syndrome and Catecholaminergic Polymorphic Ventricular Tachycardia Dental caries or unsatisfactory restorations in the mandible, indicating restorative dental treatment Exclusion Criteria: Patients allergic to lidocaine Patients undergoing ICD therapy for less than three months Patients with recurrent syncope in the last three months Patients with sustained arrhythmias documented for less than 3 months Have received epinephrine in the last 24 hours
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Itamara LI Neves, PhD
Organizational Affiliation
Instituto do Coração do HCFMUSP
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ana CG Oliveira, S
Organizational Affiliation
Instituto do Coração do HCFMUSP
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ricardo S Neves, PhD
Organizational Affiliation
Instituto do Coração do HCFMUSP
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Luciana Sacilotto, S
Organizational Affiliation
Instituto do Coração do HCFMUSP
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Francisco CC Darrieux, PhD
Organizational Affiliation
Instituto do Coração do HCFMUSP
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Maurício I Scanavacca, PhD
Organizational Affiliation
Instituto do Coração do HCFMUSP
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Denise Hachul, PhD
Organizational Affiliation
Instituto do Coração do HCFMUSP
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Cesar J Gruppi, PhD
Organizational Affiliation
Instituto do Coração do HCFMUSP
Official's Role
Study Director
Facility Information:
Facility Name
Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
City
São Paulo
ZIP/Postal Code
05403000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After thesis defense, the IPD will be available on the Portal Digital Library of Theses and Dissertations of the University of São Paulo (http://www.teses.usp.br/index.php?option=com_jumi&fileid=12&Itemid=77&lang=pt-br), in a PDF file.
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Safety of Local Dental Anesthesia in Patients With Cardiac Channelopathies

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