Local Anesthesia With Epinephrine for Oral Surgery in Type 2 Diabetes Mellitus With Corornary Disease is Safe and Effective
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- varition in blood glucose levels during oral surgery with local anaesthesia (lidocaina and lidocaine with epinephrine)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus pharmacologically controlled (in use of insulin and/or hypoglycemic agents) Coronary disease -
排除标准
- •Pregnant sepsis acute renal failure
结局指标
主要结局
varition in blood glucose levels during oral surgery with local anaesthesia (lidocaina and lidocaine with epinephrine)
时间窗: 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.
次要结局
- Hemodynamic effects during the surgery with local anesthetia (lidocaine and lidocaine with epinephrine)(almost 3 hours)