A Test of Neural Inertia in Humans With Xenon
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- xenon concentrations at which consciousness is lost and regained
研究概览
简要总结
The dual objectives of this study are to determine if the phenomenon of neural inertia is present in humans and to determine whether the order of neurocognitive function is invariant among anesthetic agents. This study will enroll 24 healthy volunteers, ages 20-40 years, who will receive xenon gas (concentrations ranging from 0% to 60%) delivered via inhaled route through the ENHANCER 3000.
详细描述
This is a multimodal, nonrandomized study of healthy subjects. After meeting enrollment criteria, subjects will receive a baseline neurocognitive testing on a computer for 15 minutes and will then receive a wrist watch actigraphy device to record their rest/activity patterns over 8-14 days. On the study day (roughly two weeks later), repeat baseline neurocognitive testing will be performed after subjects are fitted with a high density EEG head cap. The actual intervention (delivery of inhaled xenon gas in stepwise increasing followed by decreasing doses) should occur over 2 hours along with verbal tests to assess the presence/absence of consciousness at each xenon concentration. Xenon doses have been chosen specifically to evaluate the point at which individuals lose and then regain consciousness. Doses are escalated up through those used in human anesthesiology (75%) that permit surgery. After exposure, serial neurocognitive testing will occur every 30 minutes for 3 hours post emergence. Subjects are discharged from the study's intervention day to home only upon reaching standard post-anesthesia care unit criteria (modified Aldrete score ≥9). A post-procedure follow up phone call will occur within 24 hours of anesthetic exposure to ensure that the subject remains well. The individual's involvement is completed upon returning the Actigraphy watch 1 week after the exposure day. The expected duration of subject participation is up to 3 weeks.
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
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers ages 20-40 years old
- •American Society of Anesthesiologists (ASA) Physical Status I or II (i.e. healthy)
- •Body Mass Index <30 kg/m2
- •Easily visible uvula
排除标准
- •Any physical signs that would suggest a difficult airway (e.g. mouth opening <3cm, short distance between the chin and neck, poor mandibular subluxation, thick neck)
- •History of reactive airway disease
- •Current or history of neuropsychiatric disorders
- •History or current use of psychotropic medications,
- •History or current obstructive sleep apnea
- •Current or history of cardiovascular disease or arrhythmias,
- •Current or history of chronic sleep disorders
- •History of postoperative nausea/vomiting
- •Family history of problems with anesthesia (including but not limited to malignant hyperthermia),
- •Current or history of Motion sickness
- •Current tobacco use
- •Current pregnancy or currently breastfeeding
- •Positive urine toxicology screen
- •History of seizure disorder, head injury, or brain tumor
- •Alcohol consumption greater than 12 drinks per week or more than 4 drinks on any single day
- •Inability to provide informed consent
- •Inability to achieve mask seal on intervention day
研究组 & 干预措施
Xenon
Xenon anesthesia to determine if neural inertia is present in humans as visualized by CT imaging.
干预措施: Xenon (Drug)
结局指标
主要结局
xenon concentrations at which consciousness is lost and regained
时间窗: 4 hours
To determine in healthy human volunteers if the brain concentrations of xenon (as determined by CT imaging) are identical at the point of loss and return of consciousness.
Xenon Concentrations at Which Consciousness is Lost and Regained
时间窗: 4 hours
To determine in healthy human volunteers if the brain concentrations of xenon (as determined by CT imaging) are identical at the point of loss and return of consciousness. If the values are significantly different, then we conclude that there is evidence for hysteresis in circuits regulating arousal.
次要结局
- Neurocognitive recovery upon emergence from xenon as measured by neurocognitive battery testing(4 hours)
- Effects of xenon on gross motor activity as measured by actigraphy(3 weeks)
- Effects of xenon on brain electrical activity as measured by EEG(4 hours)
- Neurocognitive Recovery Upon Emergence From Xenon as Measured by Neurocognitive Battery Testing(4 hours)
- Effects of Xenon on Gross Rest / Activity as Measured Using Wristwatch Actigraphy(1 week prior to xenon exposure and 1 week post xenon exposure)
- Effects of Xenon on Brain Electrical Activity as Measured by EEG Delta Power(4 hours)