Does Dilution of Verapamil With Normal Saline or Blood Reduce Discomfort Felt During Intraarterial Administration?
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Radial Artery Spasm
研究概览
简要总结
This study will be a randomized, single-blind, prospective trial designed to evaluate the efficacy and safety of intra-arterial (IA) Verapamil diluted with normal saline compared to undiluted IA Nicardipine during transradial access (TRA) for percutaneous coronary angiography. Patients who are 18 years or older and undergoing non-emergent percutaneous coronary angiography via TRA will be included. Patients who are non-English speaking, pregnant, or intubated will be excluded. Patients will be randomized to one of the two following groups:
- Group 1 will receive IA Verapamil 5 mg (2mL) diluted with 8 mL of normal saline
- Group 2 will receive IA Nicardipine 400 mcg (undiluted, 8 mL)
The investigators will document the patient's level of discomfort on the Visual Analogue Scale 30 seconds before and after administration of IA Verapamil/Nicardipine. The investigators will also document the presence of radial artery spasms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Verapamil
Intra-arterial Verapamil 5 mg (2mL) diluted with 8 mL of normal saline
干预措施: Verapamil (Drug)
Nicardipine
Intra-arterial Nicardipine 400 mcg undiluted (8mL)
干预措施: Nicardipine (Drug)
结局指标
主要结局
Radial Artery Spasm
时间窗: approximately 30 minutes
The investigators will document the presence or absence of radial artery spasms with either 0,1, or 2. 0 will indicate no radial artery spasms. 1 will indicate radial artery spasms that did not require a change in strategy. 2 will indicate radial artery spasms that required a change in strategy such as alternate access.
Pain Prior to Intra-arterial Calcium Channel Blocker Administration
时间窗: 30 seconds prior to administration
Pain prior to intra-arterial calcium channel blocker administration will be assessed through the Visual Analogue Pain scale (from 0 to 10).
Pain After Intra-arterial Calcium Channel Blocker Administration
时间窗: 30 seconds post administration
Pain after intra-arterial calcium channel blocker administration will be assessed through the Visual analogue Pain Scale (from 0 to 10).
次要结局
未报告次要终点
研究者
Khalil Ibrahim
Assistant Professor of Clinical Medicine
University of Illinois at Chicago