A Post Marketing Surveillance to Monitor the Safety of ULTIVA (Remifentanil) Adminstered in Korean Subjects According to the Prescribing Information
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 775
- 主要终点
- Number of Participants With an Unexpected Serious Adverse Event
研究概览
简要总结
This study is a post-marketing surveillance to monitor safety and efficacy of remifentanil during various surgeries and identify SAEs, adverse drug reactions, and unexpected AEs not described as precautions or warnings and to identify prognostic factors that have an effect on the AEs and to assess effectiveness of remifentanil in real clinical practices after marketing.
The subjects are patients prescribed for remifentanil by the investigators at the sites based on prescription information in normal clinical practices.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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 requiring general anesthesia
排除标准
- •According to precautions or warnings on PI, remifentanil should not be administered to the following patients
- •Patients with any allergic reaction to any ingredients of remifentanil or other fentanyl analogues
研究组 & 干预措施
Remifentanil
Patients administrated remifentanil at the site
干预措施: Remifentanil (Drug)
结局指标
主要结局
Number of Participants With an Unexpected Serious Adverse Event
时间窗: 24 hours
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. An unexpected event is an event that is not listed in the approval product information and is not described as a precaution or warning.
次要结局
- Number of Participants With the Indicated Unexpected Adverse Event(24 hours)
- Number of Participants With an Adverse Event(24 hours)
- Number of Participants With a Serious Adverse Event(24 hours)