NCT01003028尚未招募4 期
Reduction of Remifentanil-related Complications by Limiting Maximum Plasma Concentration During Target-controlled Infusion
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- hypotension more than 25% from baseline
研究概览
简要总结
This study is intended to evaluate the effect of decreasing the maximum plasma concentration target of remifentanil of the Target Controlled Infusion system on the the incidence of major and minor side-effects.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-70 year old
- •ASA class 1-3 scheduled for elective surgery
排除标准
- •history of neurologic or mental disorder
- •uncontrolled pulmonary or cardiovascular disease
- •history of adverse reactions to opioids
- •history of drug abuse
研究组 & 干预措施
Limited
Experimental
Limit the maximum plasma concentration target to 9.8 ng/ml
干预措施: Remifentanil (Limited) - Target Controlled Infusion system (Drug)
Control
Active Comparator
Use 20 ng/ml as max plasma concentration
干预措施: Remifentanil (Control) - Target Controlled Infusion system (Drug)
结局指标
主要结局
hypotension more than 25% from baseline
时间窗: during remifentanil loading
次要结局
未报告次要终点
研究者
Chul-Woo Jung
Assistant professor
Seoul National University Hospital
研究点 (1)
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