Neuroimaging of Anesthetic Modulation of Human Consciousness
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change From Baseline in Blood Oxygen Level Dependent (BOLD) Response to Sensory Stimuli During Sedation
研究概览
简要总结
This study's purpose is to see if mental functions take place during different levels of anesthesia, using a commonly used drug (Propofol). fMRI (functional Magnetic Resonance Imaging, or "brain imaging") shows areas in the brain involved in thinking at different depths of anesthesia.
详细描述
Administering anesthetic drugs to suppress consciousness is an imperatively important step in major surgical operations. Yet the neurobiological mechanisms that underlie loss of consciousness under general anesthesia remain elusive. Despite advancements in understanding the molecular, synaptic, and cellular effects of anesthetics, the large-scale, systems-level modulation of neuronal processes that support conscious cognitive functions is incompletely understood. While profound decreases in global and regional brain metabolism, blood flow, and functional connectivity have been reported, these changes often fail to correlate with the loss and return of consciousness. To date, there is no "consciousness meter" or "gold standard" to objectively assess and monitor the level of consciousness under general anesthesia. Several studies suggest that residual cognitive functions may not completely vanish under general anesthesia; however, the level and complexity of residual information processing in the anesthetized brain remains unknown. Finally, the neurobiological mechanisms that govern anesthesia induction and emergence appear to be partially different, but the relevance of these differences to the modulation of the state of consciousness is unclear.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must have a body mass index (BMI) less than
- •Must be right handed
- •Must be English speaking
- •Must be capable of giving written informed consent.
- •Must have history of playing tennis (or any type of racquet sport) at least 30 times over lifetime.
排除标准
- •History of obstructive sleep apnea;
- •History of a difficult airway with a previous anesthetic;
- •History of neurological disorders;
- •Hypertension or other cardiovascular abnormalities;
- •Pulmonary hypertension or other pulmonary abnormalities;
- •Gastroesophageal reflux disease (GERD) or heartburn;
- •History of significant head injury with loss of consciousness;
- •Learning disability or other developmental disorder;
- •Allergic reactions to eggs;
- •Pregnant or nursing mothers;
- •Contraindications to neuroimaging methods;
- •Inability or unwilling to fast, or withhold food and liquid intake, for 8 hours prior to your scheduled study visit.
- •Unwilling to abstain from alcohol use for 24 hours prior to your scheduled study visit.
- •History of drug use, or have a positive drug screen.
- •Tattoos on the head or neck region - all other tattoos are subject to determination by investigators.
- •Any impairment, activity or situation that in the judgment of the study coordinator or Principal Investigators would prevent satisfactory completion of the study protocol.
研究组 & 干预措施
Propofol Administration
干预措施: Propofol (Drug)
结局指标
主要结局
Change From Baseline in Blood Oxygen Level Dependent (BOLD) Response to Sensory Stimuli During Sedation
时间窗: Baseline to 90 minutes
Change = BOLD Response During Sedation - BOLD Response During Baseline
次要结局
- Change From Baseline in Squeeze Pressure(Baseline to 90 minutes)
研究者
Anthony G Hudetz
Professor of Anesthesiology
University of Michigan