Randomized Controlled Trial Examining the Effect of Subcutaneous Xylocaine 2% on the Incidence of Vasovagal Reactions and Pain Intensity During Femoral Artery Sheath Removal.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Incidence of vasovagal reaction during femoral sheath removal
研究概览
简要总结
This randomized controlled trial will examine the impact of local anesthetic on the frequency of vasovagal reactions and the patients perception of pain during femoral arterial sheath removal after percutaneous coronary intervention.
详细描述
Patients undergoing percutaneous coronary intervention(PCI) will be randomized to receive subcutaneous local anesthetic (Lidocaine 2% without epinephrine)or no local prior to removal of femoral arterial sheath. They will be assessed for vasovagal reactions and pain intensity during the sheath removal.The incidence of vasovagal reactions and pain intensity scores will be compared between the groups. 200 patients will be enrolled over the course of 2 months.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Percutaneous Coronary Intervention
- •Femoral arterial sheath
排除标准
- •Less than 18 years old
- •Emergency procedure
- •Transferred out of heart investigation unit prior to sheath removal
- •Radial or brachial sheath
- •Closure devise
- •Venous sheath insitu
- •Intra-aortic balloon pump insitu
- •Tranvenous pacing
- •Mechanical ventilation
- •Cognitive impairment
- •Unable to read English
- •Lidocaine allergy
结局指标
主要结局
Incidence of vasovagal reaction during femoral sheath removal
时间窗: During sheath removal
Pain intensity during femoral sheath removal
时间窗: During sheath removal
次要结局
未报告次要终点