Anesthesia for Dental Treatment in Cardiac Patients: Lidocaine Comparative Study
| Tracking Information | |||||
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| First Received Date ICMJE | April 29, 2008 | ||||
| Last Updated Date | April 30, 2008 | ||||
| Start Date ICMJE | January 2003 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
arrhythmias [ Time Frame: during procedure ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00669838 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | |||||
| Original Other Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Anesthesia for Dental Treatment in Cardiac Patients: Lidocaine Comparative Study | ||||
| Official Title ICMJE | Loco Regional Anesthesia for Dental Treatment in Cardiac Patients: Comparative Study Between Plain Lidocaine 2% and Lidocaine 2% With Epinephrine 1:100.000 | ||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Biospecimen | |||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | 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 |
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| Condition ICMJE |
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| Intervention ICMJE | |||||
| Study Group/Cohort (s) |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 59 | ||||
| Completion Date | July 2005 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Brazil | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00669838 | ||||
| Other Study ID Numbers ICMJE | CAP432-03 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Joaquim Edson Vieira, Divisão de Anestesia, Hospital das Clínicas da FMUSP | ||||
| Study Sponsor ICMJE | University of Sao Paulo | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | University of Sao Paulo | ||||
| Verification Date | April 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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