Anesthesia With Epinephrine in Diabetes Patients is Safe and Effective

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Local Anesthesia With Epinephrine for Oral Surgery in Type 2 Diabetes Mellitus With Corornary Disease is Safe and Effective

Conditions
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Type 2 Diabetes Mellitus, Coronary Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes mellitus pharmacologically controlled (in use of insulin and/or hypoglycemic agents) Coronary disease - Exclusion Criteria: Pregnant sepsis acute renal failure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 2% lidocaine<br>35 patients received 5.4 mL of 2% lidocaine. | |
| 2% lidocaine with epinephrine<br>35 patients recieved 5.4 mL of 2% lidocaine with 1:100,000 epinephrine. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes mellitus, Epinephrine, Anesthesia, Dental, lidocaine, Ambulatory Surgical Procedures