NCT02735018已完成4 期
Randomized Double-blind Clinical Trial Comparing the Cardiovascular Effects of Local Anesthesia Solutions Containing 1:100,000 and 1:200,000 of Epinephrine Concentrations
Rio de Janeiro State University0 个研究点目标入组 40 人开始时间: 2014年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Bleeding, evaluated by the surgeon as either: 1) normal or 2) excessive
研究概览
简要总结
The study aim to evaluate systemic response of patients when 2 different concentrations of Epinephrine are injected during inferior alveolar nerve block for wisdom teeth extraction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 13 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Class I patients according to the American Society of Anesthesiology (ASA),
- •Indication for third molars extraction,
- •Similar degree of complexity, according to the classification of Pell and Gregory.
排除标准
- •Patients with systemic conditions,
- •Patients with known allergy to any component of the anesthetic solution.
结局指标
主要结局
Bleeding, evaluated by the surgeon as either: 1) normal or 2) excessive
时间窗: 20 minutes
Blood pressure
时间窗: 20 minutes
Pain, evaluated using a visual analogue scale
时间窗: After procedure, about 1 hour
Arterial oxygen saturation, measured with a pulse oximeter device
时间窗: 20 minutes
Heart rate
时间窗: 20 minutes
次要结局
未报告次要终点
研究者
Fabio Ritto
DDS, MD, MS, PhD, Program Director
Rio de Janeiro State University
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