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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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The purpose of this study is to investigate the variation in blood glucose levels, hemodynamic effects and patient anxiety score during tooth extraction in type 2 diabetes mellitus with coronary disease patient under local anesthesia with lidocaine 2% with and without epinephrine.
This is a prospective randomized study including 70 diabetes with coronary disease patients that needed to be submitted to oral surgery. The study was double blind in relation to glycaemia measurements. Continuous monitoring of blood glucose levels for 24 hours was performed using the Minimed Continuous Monitoring System (CGMS, Medtronic). Patientes were randomized into two groups: 35 received 5.4 mL of 2% lidocaine and 35 received 5.4 mL of 2% lidocaine with 1:100,000 epinephrine. In addittion, hemodynamic effects (blood pressure and heart rate) and degree of anxiety were also evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2% lidocaine | 35 patients received 5.4 mL of 2% lidocaine. | ||
| 2% lidocaine with epinephrine | 35 patients recieved 5.4 mL of 2% lidocaine with 1:100,000 epinephrine. |
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| Measure | Description | Time Frame |
|---|---|---|
| varition in blood glucose levels during oral surgery with local anaesthesia (lidocaina and lidocaine with epinephrine) | To asses the blood glucose levels the Continuous monitoring system (MiniMed CGMS, Medtronic) was employed. The MiniMed monitor was installed in the morning of the day before the surgery and the patient went to home. The patient returned to the hospital for the surgery 24 hours later and the monitor was retired one hour after the end of the oral surgery. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Hemodynamic effects during the surgery with local anesthetia (lidocaine and lidocaine with epinephrine) | Systolic blood pressure, diastolic blood pressur and heart rate were recorded by automatic sphygmomanometer (Microlife APA-P00001) in four times: one hour before the surgery, five minutes before the surgery, after anesthesia injection and one hour after the surgery. | almost 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety levels during the oral surgery with local anesthesia (lidocaine and lidocaine and epinephrine) | Anxiety levels was measurement by the Image Facial Scale at the times: one hour before the surgery, five minutes before the surgery and one hour after the surgery. | almost 3 hours |
Inclusion Criteria:
Type 2 diabetes mellitus pharmacologically controlled (in use of insulin and/or hypoglycemic agents) Coronary disease -
Exclusion Criteria:
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We enrolled pharmacologically controlled type 2 diabetes mellitus (in use of insulin and/or hypoglycemic agents) and with coronary disease adult patient who needed to have at least one posterior maxillary tooth to be extracted.
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| Name | Affiliation | Role |
|---|---|---|
| Marcela A Santos, PhD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit of Dentistry, Heart Institute | São Paulo | São Paulo | 05403-900 | Brazil |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 20, 2017 | |
| Reset | Nov 3, 2017 | |
| Release | Oct 5, 2021 | |
| Reset | Nov 2, 2021 | |
| Release | Apr 4, 2022 | |
| Reset | Oct 27, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 20, 2017 | Nov 3, 2017 | |||
| Oct 5, 2021 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003327 | Coronary Disease |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Type 2 diabete mellitus (in use of insulin and/or hypoglicemic agents) with coronary disease adults patients who needes to have at least one posterior maxillary tooth extracted, according to oral examination and panoramic radiography.
| Nov 2, 2021 |
| Apr 4, 2022 | Oct 27, 2022 |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |