The Efficacy of Papaverine to Prevent Radial Artery Spasm During Transradial Cerebral Angiography: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- The incidence of RAS
研究概览
简要总结
Rationale:Papaverine is effective on radial artery spasm during transradial cerebral angiography.
Purpose: This multicenter, randomized, placebo-controlled, double blind, phase 2b trial aims to investigate the effect and safety of papaverine in treating radial artery spasm during transradial cerebral angiography.
详细描述
Radial artery spasm (RAS) is a common complication during transradial cerebral angiography. RAS can lead to severe pain and remains the most frequent cause of transradial angiography failure. There is currently no consensus on the prevention strategy for RAS.
Papaverine has anti vasospasm, sedative and analgesic effects. However, there is no evidence for the efficacy of papaverine in preventing RAS.
This multicenter, randomized, double blind, placebo-controlled trial aims to investigate the effect and safety of papaverine in treating radial artery spasm during transradial cerebral angiography.
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
- •All patients scheduled for cerebral angiography will be eligible for screening.
- •Participant is willing and is able to give informed consent for participating in the trial.
- •Male or Female, aged 18 years or above.
排除标准
- •Any patient with negative modified Allen test
- •Altered liver function
- •atrioventricular heart block III degree
- •Suspected or confirmed cerebral hemorrhage patients
- •Hemodynamic Instability : systolic pressure < 100 mmHg, heart rate > 100 bpm, tachycardia uncontrollable.
- •Patients with cerebral edema and increased intracranial pressure within 24 hours to 2 weeks after stroke
- •Coronary artery bypass grafting(CABG) operation history and whose right radial artery is missing as a "bridge vessel"
- •Severe skin musculoskeletal malformation of forearm or failure to complete radial artery puncture and sheath placement for other reasons
- •Hypersensitivity or contraindication to papaverine
- •Hypersensitivity or contraindication to nitroglycerine
- •Glaucomatous patients
- •Parkinson's disease patients
- •Women who are suspected or known to be pregnant or breastfeeding
研究组 & 干预措施
Papaverine
Slowly inject 10ml of papaverine hydrochloride solution (30mg/10ml) through the successfully implanted radial artery sheath, and continuously drip papaverine hydrochloride solution (60mg/500ml, 4ml/min) through the artery sheath during the operation. The compatible solutions are normal saline(0.9%);
干预措施: Papaverine Hydrochloride (Drug)
Placebo
After inserting the radial artery sheath, slowly inject 10ml normal saline(0.9%) through the artery sheath, and continuously drip normal saline(0.9%, 500ml, 4ml/min) through the artery sheath during the operation.
干预措施: normal saline (Drug)
结局指标
主要结局
The incidence of RAS
时间窗: Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes.
The primary outcome of this trial is to evaluate the incidence of RAS during surgery. The operator assessed RAS on the basis of a questionnaire addressing the following five signs: persistent forearm pain, pain response on catheter manipulation, pain response to introducer withdrawal, difficult catheter manipulation after being "trapped" by the radial artery with considerable resistance on withdrawal of the introducer. RAS was considered to be indicated by the presence of at least 2 of these 5 signs or by the presence of just 1 when the operator considered it necessary to administer other spasmolytic agent.
次要结局
- The pain intensity of the right forearm(Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes.)
- The incidence of transradial approach failure(Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes.)