NCT01536002已完成4 期
Pharmacokinetics (PK) of Propofol in Bariatric (Morbidly Obese) Patients
Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2011年6月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Propofol plasma concentrations
研究概览
简要总结
The objectives of this study are
- To determine PK of propofol in bariatric patients
- To identify the physiological variables that induce propofol PK changes in bariatric patients, when compared to a normal-weight population.
- To define context-sensitive half-time profiles for propofol in bariatric patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Consecutive patients admitted to the Aker University Hospital, scheduled for general or bariatric surgery,
- •Both genders. Female subjects of childbearing potential must be using adequate contraception (i.e. using oral or IM contraception or an IUCD) and must have a negative pregnancy test (urine beta-HCG).
- •Aged 18 - 60 years, both inclusive
- •Body mass index (BMI) ≥ 20 kg/m2
- •Written informed consent
排除标准
- •Patients that are considered not to tolerate a standard dose of propofol administered as a bolus.
- •Known hypersensitivity to propofol or its ingredients (soy, lecithin, glycerol, oil acid)
- •Known hypersensitivity to any of the anesthetic agents to be used
- •Pregnant women
- •Lactating women
研究组 & 干预措施
Pharmacokinetics
Experimental
Propofol pharmacokinetics
干预措施: Propofol (Drug)
结局指标
主要结局
Propofol plasma concentrations
时间窗: 0-24 hours
Arterial blood samples will be collected 0, 1, 2, 4, 8, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 480, 600, 720, and 1440 min after start of propofol bolus infusion. 2 samples will be collected at 0 and 1440 minutes, respectively. The remaining 6 blood samples will be collected according to a block sampling regimen, selected randomly within a time block containing 4 consecutive time points from the time point list noted above. In total 8 samples are drawn from each patient.
次要结局
未报告次要终点
研究者
Tom Heier
Professor
Oslo University Hospital
研究点 (1)
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