Methoxyflurane and Fentanyl in the Lower Body Negative Pressure Model of Hypovolemia in Healthy Volunteers; a Randomized, Placebo-controlled Crossover Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Cardiac output
研究概览
简要总结
The study is a single-centre, placebo-controlled, crossover study on healthy volunteers aiming to explore non-inferiority of methoxyflurane and fentanyl compared to placebo on the tolerance to hypovolemia.
详细描述
The study will explore the effects of fentanyl and methoxyflurane versus placebo (NaCl; saline) on the hemodynamic response to hypovolemia in healty volunteers. Hypovolemia will be induced in the "lower body negative pressure" model. XX healthy volunteers will be exposed to inhaled methoxyflurane, 3 ml or intravenous fentanyl, XX mg or placebo in a randomized order (cross-over) at least 3 days apart.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Both drug interventions (intravenous fentanyl and inhaled methoxyflurane) will have NaCl placebo comparators. As the methoxyflurane has a characteristic smell, some drops of methoxyflurane will be placed on the exterior of the placebo methoxyflurane inhalation devices. Further, the subjects will rinse the mouth with a mouthwash shortly before inhalation to cover the taste of methoxyflurane.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be at least 18 years of age.
- •Must be below 65 years of age.
- •Signed informed consent and expected cooperation for the study and follow up must be obtained and documented according to ICH GCP, and national/local regulations.
排除标准
- •Any medical condition limiting physical excertional capacity or requiring regular medication (allergy and oral contraceptives excepted)
- •Pregnancy
- •History of syncope (syncope of presumed vasovagal nature with known precipitating factor excepted)
- •Any known cardiac arrhythmia
- •History of renal disease
- •History of liver disease
- •Previous substance abuse
- •Allery or known serious side-effects to opioids or methoxyflurane
结局指标
主要结局
Cardiac output
时间窗: Measured continuously during LBNP-exposure.
Cardiac output as measured by suprasternal Doppler and/ or non-invasive (volume clamp) pulse contour analysis.
次要结局
- Time to hemodynamic decompensation(15 minutes)
- Mean arterial pressure(Measured continuously during LBNP-exposure.)
- Stroke volume(Measured continuously during LBNP-exposure.)
研究者
Lars Øivind Høiseth
Overlege, PhD
Oslo University Hospital