Clinical trial NCT03182777: Safety of Local Dental Anesthesia in Patients With Cardiac Channelopathies
Official title: Safety of Local Dental Anesthesia in Patients With Cardiac Channelopathies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Channelopathies
Brugada Syndrome
Long QT Syndrome
Ventricular, Tachycardia
Keywords: arrhythmias, cardiac
channelopathies
death, sudden
genetic testing
electrocardiography, ambulatory
anesthesia, local
dentistry
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2017-06-09
Enrollment: 31
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: No sustained ventricular tachycardia
timeFrame: during dental procedures
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Study officials:
affiliation: Instituto do Coração do HCFMUSP
name: Itamara LI Neves, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto do Coração do HCFMUSP
name: Ana CG Oliveira, S
role: STUDY_CHAIR
affiliation: Instituto do Coração do HCFMUSP
name: Ricardo S Neves, PhD
role: STUDY_DIRECTOR
affiliation: Instituto do Coração do HCFMUSP
name: Luciana Sacilotto, S
role: STUDY_CHAIR
affiliation: Instituto do Coração do HCFMUSP
name: Francisco CC Darrieux, PhD
role: STUDY_CHAIR
affiliation: Instituto do Coração do HCFMUSP
name: Maurício I Scanavacca, PhD
role: STUDY_DIRECTOR
affiliation: Instituto do Coração do HCFMUSP
name: Denise Hachul, PhD
role: STUDY_CHAIR
affiliation: Instituto do Coração do HCFMUSP
name: Cesar J Gruppi, PhD
role: STUDY_DIRECTOR
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