Anesthesia for Dental Treatment in Cardiac Patients: Lidocaine Comparative Study
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Purpose
Prospective, randomized double-blinded study to investigate hemodynamic changes in valvular cardiac patients during dental treatment with the use of a local anesthesia containing epinephrine.
| Condition |
|---|
|
Arrhythmias Anxiety |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Loco Regional Anesthesia for Dental Treatment in Cardiac Patients: Comparative Study Between Plain Lidocaine 2% and Lidocaine 2% With Epinephrine 1:100.000 |
- arrhythmias [ Time Frame: during procedure ] [ Designated as safety issue: Yes ]
- Arterial pressure [ Time Frame: during procedure ] [ Designated as safety issue: Yes ]
- anxiety [ Time Frame: during and imediately after procedure ] [ Designated as safety issue: Yes ]
| Enrollment: | 59 |
| Study Start Date: | January 2003 |
| Study Completion Date: | July 2005 |
| Groups/Cohorts |
|---|
|
PL
Patients who receive local anesthesia with 2% lidocaine without epinephrine
|
|
LE
Patients who receive local anesthesia with 2% lidocaine with 1:100.000 epinephrine
|
Detailed Description:
Patients with valvular disease constitute a group in which local anesthesia must be effective to avoid higher release of endogenous catecholamines that could trigger hemodynamic. The study was conducted in the Dental Department of the Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (Brazil). Patients were allocated into two groups through an aleatory numbered table: PL (plain 2% lidocaine, n= 31) and LE (2% lidocaine with 1:100.000 epinephrine, n= 28). The anesthetic amount was registered. DIXTAL monitor (São Paulo- Brazil) captured blood pressure, heart rate, oxygenation and electrocardiogram records.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with acquired valvular diseases participated in this study, aging between 18-65 years in need of dental surgery (extractions) or restorative dentistry in mandible
Inclusion Criteria:
- Patients with acquired valvular disease
Exclusion Criteria:
- Patients having platelets counting lower than 70.000 or INR > 3
Contacts and Locations| Brazil | |
| Hospital das Clínicas da FMUSP | |
| Sao Paulo, Brazil, 05430 010 | |
| Principal Investigator: | Joaquim E Vieira, MD, PhD | University of Sao Paulo Medical School - FMUSP |
More Information
No publications provided
| Responsible Party: | Joaquim Edson Vieira, Divisão de Anestesia, Hospital das Clínicas da FMUSP |
| ClinicalTrials.gov Identifier: | NCT00669838 History of Changes |
| Other Study ID Numbers: | CAP432-03 |
| Study First Received: | April 29, 2008 |
| Last Updated: | April 30, 2008 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by University of Sao Paulo:
|
Anesthesia, Local Lidocaine Dental care Arrhythmias, Cardiac Anxiety |
Additional relevant MeSH terms:
|
Anxiety Disorders Arrhythmias, Cardiac Mental Disorders Heart Diseases Cardiovascular Diseases Pathologic Processes Epinephrine Lidocaine Anesthetics Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Mydriatics Adrenergic alpha-Agonists Sympathomimetics Vasoconstrictor Agents Cardiovascular Agents Central Nervous System Depressants Central Nervous System Agents Anesthetics, Local |
ClinicalTrials.gov processed this record on May 22, 2013