A Pharmacokinetic Study of Sevoflurane Inhalation in Burn ICU Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Determination of plasmatic concentrations of sevoflurane
研究概览
简要总结
Comparing a pharmacokinetic model of a short sevoflurane sedation in burn ICU patients with control ICU patients.
详细描述
Prospective clinical study in ICU with sedated ventilated patients with sevoflurane with the AnaConda® system, establishing pharmacokinetic model of sevoflurane and its metabolites (hydroxyfluroisopropanol, fluoride) comparing burn and non burn ICU patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 requiring invasive procedure in ICU
- •Stable respiratory and hemodynamic conditions
- •Consent of patients or family
- •Arterial line
- •Burn patients : burn area between 20 and 50% (3rd degree) OR non burn patients
排除标准
- •Sevoflurane anaphylaxia
研究组 & 干预措施
burn ICU patients
Determination of plasmatic concentrations of sevoflurane at different times of a short term sedation of sevoflurane in burn versus non burn ICU patients
干预措施: Short term sedation with sevoflurane in ICU (Drug)
non burn ICU patients
Determination of plasmatic concentrations of sevoflurane at different times of a short term sedation of sevoflurane in burn versus non burn ICU patients
干预措施: Short term sedation with sevoflurane in ICU (Drug)
结局指标
主要结局
Determination of plasmatic concentrations of sevoflurane
时间窗: at 5min, 15 min, 60 min and just before the end of sedation.
次要结局
- Determination of plasmatic concentrations of HFIP and fluoride(at 5min, 15 min, 60 min and just before the end of sedation. And 5min, 10 min, 30 min, 60 min and 120 min after the end of sedation)