Anesthesia With Epinephrine in Diabetes Patients is Safe and Effective

Completed

• Conditions: Type 2 Diabetes Mellitus; Coronary Disease

• Registration Number: NCT02173067
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-09
• Status Verified: 2012-10
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Study First Submitted: 2014-06-23
• Study First Submitted QC: 2014-06-23
• Last Update Submitted: 2014-06-23
• Study First Posted: 2014-06-24
• Last Update Posted: 2014-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
varition in blood glucose levels during oral surgery with local anaesthesia (lidocaina and lidocaine with epinephrine)	24 hours	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.

Secondary Outcome Measures

Name	Time	Method
Hemodynamic effects during the surgery with local anesthetia (lidocaine and lidocaine with epinephrine)	almost 3 hours	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.

Trial Locations

Locations (1)

Unit of Dentistry, Heart Institute; 🇧🇷 São Paulo, Brazil