NCT06355882招募中不适用
Cardiovascular Events in Patients With Low Cardiac Output Undergoing Local Dental Anesthesia With and Without Epinephrine: Randomized, Double-blind Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Amount ventricular and supraventricular arrhythmia
研究概览
简要总结
Patients with low cardiac output syndrome requiring surgical and periodontal dental treatment will be selected to undergo the dental procedure using local dental anesthetic: 2% lidocaine with epinephrine and 2% lidocaine without vasoconstrictor. Cardiovascular events and the safety of using two cartridges (3.6 mL) will be evaluated. They will be evaluated by Holter monitoring in the period of 1 hour before, during and 1 hour after the procedure and blood pressure correction will be performed
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
- Double (Participant, Care Provider)
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
- •Patients with advanced heart failure, in INTERMACS III using dobutamine at 5 to 20 µg/kg/minute due to low cardiac output syndrome
- •Presence of periodontal disease, in the 4th or 6th sextant with indication of supragingival and/or subgingival periodontal scaling;
- •Residual root or teeth with periodontal disease in the jaw, with simple extraction indicated.
排除标准
- •Patients with a ventricular assist device such as an intra-aortic balloon implanted less than 24 hours after the dental procedure or with extracorporeal membrane oxygenation (ECMO);
- •Using other inotropes;
- •On mechanical ventilation;
- •Continuously using a non-invasive ventilation mask;
- •In septic shock;
- •Presence of acute myocardial infarction <30 days;
- •Patients with terminal non-cardiac disease, cyanotic congenital heart disease or cardiomyopathies with arrhythmogenic potential (arrhythmogenic dysplasia, hypertrophic cardiomyopathy, non-compacted myocardium);
- •Pregnant women;
- •History of sudden death recovered < 1 month ago;
- •In the recent postoperative period of cardiac surgery (5 days);
- •Allergic to sodium bisulfite and methylparaben, preservatives of epinephrine and the anesthetic cartridge, respectively.
结局指标
主要结局
Amount ventricular and supraventricular arrhythmia
时间窗: during dental procedures
Number of ventricular and supraventricular arrhythmias recorded using Holter
次要结局
未报告次要终点
研究者
Itamara Lucia Itagiba Neves
Principal Investigator
University of Sao Paulo General Hospital
研究点 (2)
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