Trans-radial Cardiac Catheterization Local Anesthesia: an Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Visual Analog Scale of Pain Perception during sheath insertion
研究概览
简要总结
An open label observational clinical study to compare the efficacy of EMLA cream (lidocaine 2.5% and prilocaine 2.5% in a ratio of 1:1 by weight) in comparison to the established local anesthesia (LA) protocol of lidocaine subcutaneous injection, in providing adequate peri-operative local anesthesia during transradial coronary angiography
详细描述
A total of 800 consecutive patients, who are referred for elective coronary angiography to 1st Cardiology Department cathlab, with the suspicion of coronary artery disease (CAD) will be enrolled in this study. Exclusion criteria are acute coronary syndrome, previous ipsilateral transradial approach, Raynaud's syndrome, abnormal renal function with or without need for hemodialysis, known history of sensitivity to local anesthetics, non-palpable radial pulse, abnormal Barbeau's test and patient's refusal. Baseline clinical, demographic and procedural data of the study population will be recorded.
The study will not involve any intervention but it will observe patients assigned to other EMLA cream or lidocaine injection for local anesthesia as part of their clinical routine treatment during transradial catherization.
Primary end-point: the perception of radial pain assessed during artery puncture and 30 minutes after sheath removal. Secondary end-point: The number of puncture attempts, the total time required before successful sheath insertion, and the occurrence of radial artery spasm will be also documented in each group Participants will be observed for 4 hours post angiography for development of local complications or side effects.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients, referred for elective diagnostic coronary angiography
排除标准
- •acute coronary syndrome
- •previous ipsilateral transradial approach
- •Raynaud's syndrome
- •abnormal renal function with or without need for hemodialysis
- •known history of sensitivity to local anesthetics
- •non-palpable radial pulse, abnormal Barbeau's test
- •patient's refusal
结局指标
主要结局
Visual Analog Scale of Pain Perception during sheath insertion
时间窗: During artery puncture
The primary end-point of the study is the perception of radial pain assessed during artery puncture
次要结局
- Puncture efficiency(During radial artery catheterization)
- Radial artery spasm(During radial artery catheterization)
- Visual Analog Scale of Pain Perception 30 minutes after sheath removal(30 minutes after sheath removal)
研究者
Dimitris Tousoulis
Professor of Cardiology
Hippocration General Hospital