Protocol for Eslax Intravenous Drug Use Investigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,969
- 主要终点
- incidence of adverse events
研究概览
简要总结
The main purpose of this investigation is to collect safety and efficacy information of Eslax Intravenous 25mg/2.5mL and 50mg/5.0mL (hereinafter referred to as "Eslax") in daily clinical settings.
详细描述
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients to whom Eslax has been administered to relax muscles at the time of anesthesia or tracheal intubation.
排除标准
- •Patients with a history of hypersensitivity to Eslax or bromide.
- •Patients with myasthenia gravis or myasthenic syndrome.
研究组 & 干预措施
1
Patients to whom Eslax has been administered to relax muscles at the time of anesthesia or tracheal intubation
干预措施: Rocuronium (Drug)
结局指标
主要结局
incidence of adverse events
时间窗: The standard observation period for a patient is duration of hospital stay (from one week before Eslax administration to one week after administration at a maximum).
次要结局
- intubation score(From administration of Eslax to completion of intubation)
- intubation completion time(From administration of Eslax to completion of intubation)