Sedative Premedication in Coronary Angiography
试验速览
- 阶段
- 不适用
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- periprocedural pain: visual analogue scale
研究概览
简要总结
Evaluation of the possible positive effect of sedative premedication prior to coronary angiography in regards to pain and anxiety.
详细描述
Coronary angiography is an invasive procedure that can cause patient discomfort. Sedative premedication before coronary angiography could be used to reduce anxiety and pain, but evidence is lacking. Previous trials were predominantly conducted in men and in coronary interventions with femoral access. Recently, radial access has become the preferred route for performing coronary angiograms (RIVAL trial) In this setting, sedative premedication could be of interest to reduce radial spasms, patient anxiety and pain.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective coronary angiography
排除标准
- •planned PCI
- •use of sedative medication at home
- •use of alcohol
研究组 & 干预措施
Alprazolam
Patients receive alprazolam 0.5 mg 1 hour prior to coronary angiography.
干预措施: Alprazolam 0.5 mg (Drug)
Placebo Oral Tablet
Patients receive placebo 1 hour prior to coronary angiography.
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
periprocedural pain: visual analogue scale
时间窗: Assessed after the coronary angiography, within 4 hours.
pain during to coronary angiography. Assessed after the procedure through a visual analogue scale for pain. The VAS scale is a visual scale ranging from 0 (no pain) to 100 (extreme pain).
preprocedural anxiety: visual analogue scale
时间窗: Assessed before the coronary angiography
anxiety prior to coronary angiography. Assessed before the procedure through a visual analogue scale for anxiety (VAS-A). The VAS is a visual scale ranging from 0 to 100 with 0 begin no anxiety at all and 100 begin extreme anxiety.
次要结局
- radial spasm(during procedure)
- vascular site access complication(during procedure)
研究者
Wilgenhof Adriaan
Medical Doctor, Principal Investigator
Universitair Ziekenhuis Brussel