2023-507215-35-00招募中2 期
Influence of Dexmedetomidine on the Human Glymphatic Cerebrospinal Fluid Flow, Neural Activity and Cerebral Blood Flow in Functional Magnetic Resonance Imaging (GlymphDex)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The primary outcome is the change in functional magnetic resonance signals or power spectra reflecting neural activity, brain pulsation, cerebral blood flow, and CSF flow with changing states of consciousness.
研究概览
简要总结
The aim of this study is to characterize brain pulsations, blood flow, and cerebrospinal fluid flow using functional MRI in different states of consciousness and couple these to neural activity in electroencephalography in the awake brain and under different levels of dexmedetomidine sedation.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- One-phase study
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Fluent Finnish skills
- •Head circumference max 59 cm
- •Right-handedness
- •Age 18-45 years
- •Normal baseline ECG
- •Normal blood pressure
- •Normal SpO2
- •No signs of substance abuse
- •Acceptable values in laboratory tests
- •Normal weight (BMI 18.5-30 kg/m2)
排除标准
- •Previous history of intolerance to the study drug or related compound/additive
- •Blood donation within 3 months prior to and during the study
- •Known history of snoring or obstructive sleep apnea
- •Chronic sleep disturbance
- •Previous or present alcoholism or drug abuse or tendency to drug or alcohol abuse
- •Low body weight (< 50 kg) or BMI < 18.5 kg/m2 or BMI > 30 kg/m2
- •Smoking during one month before the study or during the study
- •Inability or difficulty of lying or sleeping in horizontal supine position
- •Forearm veins evaluated difficult to cannulate
- •Any contraindication to MRI
- •Tinnitus or hearing impairment
- •Strong susceptibility to allergic reactions
- •Known history of significant anaesthetic complication
- •Strong susceptibility to nausea
- •Airway management is evaluated difficult
- •Gastroesofageal reflux
- •Pregnancy, planned pregnancy, or lactation
- •Existing regular medication (incl contraception)
- •Participation in any other clinical study involving investigational or marketed drug products concomitantly or within 3 months prior to entry to this study
结局指标
主要结局
The primary outcome is the change in functional magnetic resonance signals or power spectra reflecting neural activity, brain pulsation, cerebral blood flow, and CSF flow with changing states of consciousness.
The primary outcome is the change in functional magnetic resonance signals or power spectra reflecting neural activity, brain pulsation, cerebral blood flow, and CSF flow with changing states of consciousness.
次要结局
- • Change in any MRI signal with drug concentrations, different states of consciousness, sedation-related EEG changes, and blood biomarkers.
- • Influence of physiological parameters on MRI signals, biomarkers, and EEG.
- • Comparison of regional and tissue specific differences in MRI between different states of consciousness and with different levels of sedation.
- • Correlation between MRI data, EEG data and peripheral blood biomarkers with sleep quality on the previous night.
- • Correlation of dexmedetomdine sedation with levels of biomarkers, particularly plasma sodium, plasma osmolality, blood glucose, serum insulin, plasma copeptin and serum cortisol levels.
- • Creating a model for glymphatic CSF flow in functional MRI (i.e. typical functional MRI signal/spectra).
研究者
Terhi Lohela
Scientific
Helsinki University Central Hospital
研究点 (1)
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