Efficacy and Safety of Intraoral Local Anesthesia by Lidocaine + Clonidine in Patients With Diabetes Mellitus Type 2
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Baseline Systolic Blood Pressure
研究概览
简要总结
The purpose of this study is to determine whether 2% lidocaine (L) + clonidine (C) (15 mcg/ml) as a vasoconstrictor achieves efficient (equal or better parameters of intraoral local anesthesia in comparison to 2% lidocaine + epinephrine (E) (1:80 000)) and safe (stable cardiovascular parameters - systolic, diastolic, mean blood pressure and heart rate) intraoral local anesthesia in patients with Diabetes mellitus type 2.
详细描述
Patients with diabetes mellitus type 2, represent a risk for performing regional anesthesia techniques due to microvascular (microangiopathy, neuropathy) and macrovascular (hypertension, coronary heart disease) complications. There is evidence that local anesthetic toxicity may be increased in diabetic setting due to underlying neuropathy; while interaction of diabetic blood vessels with vasoconstrictors may be of importance because of microangiopathic changes. Lately, regional anesthesia protocol in general surgery for patients with diabetes mellitus was released, proposing reduction of local anesthetic concentration and avoiding epinephrine as vasoconstrictor.
Oral cavity tissues in diabetes mellitus also suffer from neuropathy (burning, paresthesia, teeth loss, temporomandibular dysfunction, xerostomia) and microangiopathy (periodontal disease, salivary gland dysfunction). Most widely used vasoconstrictor for intraoral local anesthesia, epinephrine, is an alpha- and beta- adrenergic agonist. Because of its beta-adrenergic effects, epinephrine could adversely affect cardiovascular function, especially in risk patients. There are data suggesting that intraoral local anesthesia obtained with 2% lidocaine with clonidine, selective alpha 2-adrenoceptor agonist as a vasoconstrictor, is characterized with significantly more stable cardiovascular parameters and similar parameters of local anesthesia with respect to lidocaine with epinephrine in healthy and hypertensive patients.
With regard to aforementioned, the aim of this randomized double-blind controlled clinical trial is to evaluate and compare efficacy and safety of intraoral local anesthesia obtained with 2% lidocaine (L) + clonidine (15 mcg/ml) (C) or 2% L + epinephrine (1:80 000) (E), comparing healthy and diabetes mellitus type 2 patients. Prior to tooth extraction, random allocation to one of four groups (L+C maxillary infiltration, L+C mandibular block, L+E maxillary infiltration and L+E mandibular block) is performed for diabetic (30 per group) and healthy (30 per group) patients. Parameters of local anesthesia (onset, duration, intensity, width of anesthetic field for maxillary infiltration), cardiovascular parameters (systolic, diastolic, mean arterial pressure; heart rate and electrocardiographic changes), quality of postoperative analgesia (assessed by Visual Analogue Scale, Numerical Rating Scale and number of consumed analgesics) and postoperative complications (infection, bleeding, paresthesia, delayed wound healing) are evaluated and compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy participants: ASA I
- •Diabetic type 2 participants: ASA III (HbA1c level < 9%)
- •Required a single-root teeth indicated for non-complicated extraction
- •Dental diagnosis of periodontal disease, tooth fracture, chronic periapical lesion and root infection
- •Subjects give informed written consent
排除标准
- •Pregnancy and lactation
- •Allergy to used drugs and food
- •Hepatic and/or renal failure
- •ASA IV patients
- •Tobacco smokers
- •History of alcoholism and/or drug abuse and addiction
研究组 & 干预措施
Diabetics: L+C maxillary anesthesia
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
干预措施: L+C maxillary anesthesia (Drug)
Diabetics: L+C mandibular anesthesia
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
干预措施: L+C mandibular anesthesia (Drug)
Diabetics: L+E maxillary anesthesia
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
干预措施: L+E maxillary anesthesia (Drug)
Diabetics: L+E mandibular anesthesia
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
干预措施: L+E mandibular anesthesia (Drug)
Healthy: L+C maxillary anesthesia
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
干预措施: L+C maxillary anesthesia (Drug)
Healthy: L+C mandibular anesthesia
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
干预措施: L+C mandibular anesthesia (Drug)
Healthy: L+E maxillary anesthesia
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
干预措施: L+E maxillary anesthesia (Drug)
Healthy: L+E mandibular anesthesia
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
干预措施: L+E mandibular anesthesia (Drug)
结局指标
主要结局
Baseline Systolic Blood Pressure
时间窗: Baseline, 0 minutes
Baseline Diastolic Blood Pressure
时间窗: baseline, 0 minutes
Diastolic Blood Pressure at 15 Minutes
时间窗: 15th minute
Diastolic blood pressure values 10 minutes after local anesthesia injection
Duration of Intraoral Local Anesthesia
时间窗: Up to 6 hours after local anesthesia injection
Time until cessation in soft tissue numbness
Intensity of Intraoral Local Anesthesia
时间窗: Up to 10 minutes after local anesthesia injection
Number of participants who reported values \> 0 after pin-prick testing, using Visual Analogue Scale (VAS) and Numerical Rating Scale (NRS). VAS is represented by line 100 mm long, with one end marked with 0 and words "no pain" , while the other end is marked with 100 and words "the worst pain imanginable". VRS scale is represented by line 100 mm long, marked with numbers from 0 to 10, where 0 corresponds to "no pain", and 10 corresponds to "the worst pain imaginable". For both scales, higher scores represent worse outcomes.
Systolic Blood Pressure at 10 Minutes
时间窗: 10th minute
Systolic blood pressure values 5 minutes after local anesthesia injection
Diastolic Blood Pressure at 20 Minutes
时间窗: 20th minute
Diastolic blood pressure values 15 minutes after local anesthesia injection
Diastolic Blood Pressure at 35 Minutes
时间窗: 35th minute
Diastolic blood pressure values 30 minutes after local anesthesia injection
Baseline Values of Heart Rate
时间窗: baseline, 0 minutes
Heart Rate at 20 Minutes
时间窗: 20th minute
Heart rate 15 minutes after local anesthesia injection, 20 minutes after baseline measurement
Diastolic Blood Pressure at 10 Minutes
时间窗: 10th minute
Diastolic blood pressure values 5 minutes after local anesthesia injection
Heart Rate at 10 Minutes
时间窗: 10th minute
Heart rate 5 minutes after local anesthesia injection, 10 minutes after baseline measurement
Systolic Blood Pressure at 15 Minutes
时间窗: 15th minute
Systolic blood pressure values 10 minutes after local anesthesia injection
Systolic Blood Pressure at 35 Minutes
时间窗: 35th minute
Systolic blood pressure values 30 minutes after local anesthesia injection
Electrocardiogram at 15 Minutes
时间窗: 15th minute
ECG 10 minutes after local anesthesia injection, 15 minutes after baseline measurement
Systolic Blood Pressure at 20 Minutes
时间窗: 20th minute
Systolic blood pressure values 15 minutes after local anesthesia injection
Heart Rate at 15 Minutes
时间窗: 15th minute
Heart rate 10 minutes after local anesthesia injection, 15 minutes after baseline measurement
Ceart Rate at 35 Minutes
时间窗: 35th minute
Heart rate 30 minutes after local anesthesia injection, 35 minutes after baseline measurement
Electrocardiogram at 10 Minutes
时间窗: 10th minute
ECG 5 minutes after local anesthesia injection, 10 minutes after baseline measurement
Baseline Electrocardiogram
时间窗: baseline, 0 minutes
Electrocardiogram at 20 Minutes
时间窗: 20th minute
ECG 15 minutes after local anesthesia injection, 20 minutes after baseline measurement
次要结局
- Local Postoperative Complications(24 hours, 7 days)
- Onset of Intraoral Local Anesthesia(Up to 10 minutes, until subjective feeling of soft tissue numbnes)
- Width of Anesthetic Field After Maxillary Infiltration Anesthesia(Up to 10 minutes after injection of local anesthesia)
- Postoperative Analgesia(up to 24 hours after tooth extraction)
研究者
Bozidar Brkovic, DDS, MSc, PhD, Professor
Professor, DDS, MSc, PhD
University of Belgrade