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临床试验/NCT02042612
NCT02042612已完成2 期

Pharmacokinetic Study of 48-hour Sevoflurane Inhalation Using a Disposable Delivery System (AnaConDa©) in Obese ICU Patients

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2013年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
8
试验地点
1
主要终点
Determination of plasmatic concentrations of sevoflurane before using AnaConda® system

研究概览

简要总结

Describing a pharmacokinetic model of 48-h sevoflurane sedation in obese ICU patients

详细描述

Prospective clinical monocentric study in ICU with sedated ventilated obese 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
分配方式
Non Randomized
干预模型
Single Group
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

入选标准

  • Adult patients ventilated more than 48 h Stable respiratory and hemodynamic conditions Consent of patients or family Arterial line BMI >30

排除标准

  • Acute kidney injury BMI <30 Sevoflurane anaphylaxia

研究组 & 干预措施

sevoflurane

Experimental

Determination of plasmatic concentrations of sevoflurane at different times of a 48h sedation of sevoflurane in obese ICU patients

干预措施: Sedation with sevoflurane during 48-hr in ICU (Drug)

结局指标

主要结局

Determination of plasmatic concentrations of sevoflurane before using AnaConda® system

时间窗: at 5min, 60 min, 24 hrs and just before the end of sedation.

次要结局

  • Determination of plasmatic concentrations of HFIP and fluoride before using AnaConda® system(at 5min, 60 min, 24 hrs and just before the end of sedation.)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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