NCT01196754已完成不适用
Pharmacokinetic of Sevoflurane During a 48h Sedation in ICU With AnaConDa®
University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2008年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Determination of plasmatic concentrations of sévoflurane at different times of a 48h sedation of sévoflurane.
研究概览
简要总结
This is a prospective clinical monocentric study in ICU with sedated ventilated patients with sevoflurane during 48 h with the AnaConda® system, establishing pharmacokinetic model of sevoflurane.
详细描述
Prospective clinical monocentric study in ICU with sedated ventilated patients with sevoflurane during 48 h with the AnaConda® system, establishing pharmacokinetic model of sévoflurane and its metabolites (hydroxyfluroisopropanol, fluoride)
研究设计
- 研究类型
- Interventional
- 主要目的
- Screening
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients ventilated more than 48 h
- •Stable respiratory and hemodynamic conditions
- •Consent of patients or family
- •Arterial line
排除标准
- •Acute kidney injury
- •Sevoflurane anaphylaxia
结局指标
主要结局
Determination of plasmatic concentrations of sévoflurane at different times of a 48h sedation of sévoflurane.
时间窗: during 48 hours
次要结局
- Determination of plasmatic concentrations of HFIP and fluoride at different times of a 48h sedation of sévoflurane. Determination of a pharmacokinetic model of sévoflurane.(during 48 hours)
研究者
研究点 (2)
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Pharmacocinétique du sévoflurane lors d’une sédation sur 48h en Réanimation avec le système AnaConDa : étude pilote.Patient de Réanimation sous ventilation artificielle nécessitant une sédation de 48 h.EUCTR2007-002925-64-FRCHU Clermont-Ferrand