Randomized Clinical Trial Comparing Transradial Catheterization With or Without Spasmolytic Drugs.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 328
- 试验地点
- 1
- 主要终点
- Pain Assessment Using Visual Analogue Scale
研究概览
简要总结
Single-center study, randomized, double-blind, placebo controlled, with patients undergoing diagnostic or therapeutic catheterization via the transradial approach. Patients will be randomized into two groups: one group will receive the vasodilator nitroglycerin during the procedure (intervention group), and a second group will receive saline 0.9% in the same volume and time during the procedure (control group).
Will be evaluated: incidence of spasms of the radial artery, ability to perform the procedure without the need to change the access site, pain presented by the patient, time and total radiation of the procedure.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Indication for cardiac catheterization
- •Suitable candidates for transradial approach
排除标准
- •Intubated patients
- •Complications during procedure (cardiac arrest, pulmonary edema, cardiogenic shock, stroke)
- •Prior inclusion in this trial
研究组 & 干预措施
Placebo
Placebo (saline solution 10 ml) in radial artery after sheath insertion
干预措施: Placebo (Other)
Intervention
Nitroglycerin (200 micrograms) + saline solution 10 ml in radial artery after sheath insertion
干预措施: Nitroglycerin (Drug)
结局指标
主要结局
Pain Assessment Using Visual Analogue Scale
时间窗: Five minutes after sheath removal
the patients' feeling of pain in the forearm, and it was measured using a visual analogue scale (VAS), applied at the end of the procedure by an interventional nurse. The VAS consists of a single line measuring 100 mm, anchored by verbal descriptors, saying 'no pain' and 'worst possible pain'. Higher values mean a worse pain.
次要结局
- Procedure Duration(Immediate)
- Radiation Exposure(Immediate)
研究者
Roberto Léo da Silva
MD
Instituto de Cardiologia de Santa Catarina