Comparison Between Midazolam and Loxapine in the Treatment of Agitated Patients in the Emergency Department
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Success of treatment at 20 min
研究概览
简要总结
Neuroleptics are used since a long time in the management of severely agitated patients. Loxapine is routinely used in our country, with, to our knowledge no severe adverse event reported, in this indication.
However, recently, benzodiazepines have appeared interesting in agitated patients, with the use of midazolam.
The aim of this study is to compare midazolam to loxapine in the treatment of severe agitated patients admitted in the emergency department.
详细描述
Prospective, Randomized, Double-blind, Multicenter study (20 french emergency departments)
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severely agitated patients (Richard Scale over or equal to 5) between 18 and 65 years old
排除标准
- •Hypoglycemia hypoxemia patients with known dementia blood pressure <90 mmHg known cocaine or amphetamine intoxication pregnancy respiratory or liver insufficiency myasthenia sedation before arrival to hospital
研究组 & 干预措施
loxapine
agitated patients were randomly assigned either to loxapine, either to midazolam group
干预措施: loxapine, midazolam (Drug)
loxapine
agitated patients were randomly assigned either to loxapine, either to midazolam group
干预措施: blood sample (Biological)
loxapine
agitated patients were randomly assigned either to loxapine, either to midazolam group
干预措施: patient monitoring (Other)
loxapine
agitated patients were randomly assigned either to loxapine, either to midazolam group
干预措施: Loxapine (Drug)
midazolam
midazolam is compared to loxapine in terms of efficacy and tolerance
干预措施: loxapine, midazolam (Drug)
midazolam
midazolam is compared to loxapine in terms of efficacy and tolerance
干预措施: blood sample (Biological)
midazolam
midazolam is compared to loxapine in terms of efficacy and tolerance
干预措施: patient monitoring (Other)
midazolam
midazolam is compared to loxapine in terms of efficacy and tolerance
干预措施: Midazolam (Drug)
结局指标
主要结局
Success of treatment at 20 min
时间窗: 20 min
次要结局
- Sedation duration
- Need for rescue medication(any time)
- Success of treatment at 40 and 60 min(40 and 60 mn)
- Agitation level at 20,40 and 60 min(20, 40 and 60mn)
- treatment failure(one hour after treatment)