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Trial record 53 of 74 for:    "Andersen-Tawil syndrome" OR "Long QT Syndrome"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03182777
Recruitment Status : Completed
First Posted : June 9, 2017
Last Update Posted : November 22, 2018
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Itamara Lucia Itagiba Neves, University of Sao Paulo General Hospital

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.

Condition or disease Intervention/treatment Phase
Channelopathies Brugada Syndrome Long QT Syndrome Ventricular, Tachycardia Procedure: Dental restorative procedure Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Safety of Local Dental Anesthesia in Patients With Cardiac Channelopathies
Study Start Date : May 2015
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018


Arm Intervention/treatment
Active Comparator: Lidocaine with epinephrine
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.
Procedure: Dental restorative procedure
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.

Active Comparator: Lidocaine
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.
Procedure: Dental restorative procedure
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 Measures :
  1. No sustained ventricular tachycardia [ Time Frame: during dental procedures ]
    No life-threatening arrhythmias and clinical signs and symptoms



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03182777


Locations
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Brazil
Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, Brazil, 05403000
Sponsors and Collaborators
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Principal Investigator: Itamara LI Neves, PhD Instituto do Coração do HCFMUSP
Study Chair: Ana CG Oliveira, S Instituto do Coração do HCFMUSP
Study Director: Ricardo S Neves, PhD Instituto do Coração do HCFMUSP
Study Chair: Luciana Sacilotto, S Instituto do Coração do HCFMUSP
Study Chair: Francisco CC Darrieux, PhD Instituto do Coração do HCFMUSP
Study Director: Maurício I Scanavacca, PhD Instituto do Coração do HCFMUSP
Study Chair: Denise Hachul, PhD Instituto do Coração do HCFMUSP
Study Director: Cesar J Gruppi, PhD Instituto do Coração do HCFMUSP

Publications:

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Responsible Party: Itamara Lucia Itagiba Neves, Principal Investigator, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03182777     History of Changes
Other Study ID Numbers: Odonto-Canalopatias
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Keywords provided by Itamara Lucia Itagiba Neves, University of Sao Paulo General Hospital:
arrhythmias, cardiac
channelopathies
death, sudden
genetic testing
electrocardiography, ambulatory
anesthesia, local
dentistry

Additional relevant MeSH terms:
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Long QT Syndrome
Syndrome
Tachycardia
Brugada Syndrome
Channelopathies
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Genetic Diseases, Inborn
Anesthetics
Lidocaine
Epinephrine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists