Anesthesia With Epinephrine in Diabetes Patients is Safe and Effective

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02173067

Enrollment

Registered

2014-06-24

Start date

2009-09-30

Completion date

2012-11-30

Last updated

2014-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Disease, Type 2 Diabetes Mellitus

Keywords

Diabetes mellitus, Epinephrine, Anesthesia, Dental, lidocaine, Ambulatory Surgical Procedures

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Other

Measure	Time frame	Description
Anxiety levels during the oral surgery with local anesthesia (lidocaine and lidocaine and epinephrine)	almost 3 hours	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.

Countries

Brazil

Outcome results