Glymphatic Clearance During Anesthesia and Sleep: A Diffusion Tensor Imaging (DTI) Study in Humans
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Glymphatic clearance from the human brain
研究概览
简要总结
This study is to assess the effect of dexmedetomidine anesthesia on glymphatic flow in 5 healthy human subjects as visualized by diffusion tensor MRI. The study is designed to measure clinically established, safe imaging of DTI and cerebral blood flow at baseline, during a continuous intravenous infusion of dexmedetomidine at doses designed to produce anesthesia-induced unconsciousness to simulate natural sleep, and again on return to wakefulness.
详细描述
Objective:
The purpose of this study is to assess the effect of dexmedetomidine anesthesia on glymphatic flow in human subjects as visualized by diffusion tensor MRI.
Study Design:
This study will take place at the University of Pennsylvania. Investigators plan to enroll approximately 30 healthy volunteers to generate pilot data for a larger grant submission.
Characteristics of the Study Population:
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
- •Person aged 20-40 years old,
- •American Society of Anesthesiologists Physical Status I or II (i.e., healthy),
- •Body mass index ≤ 30 kg/m2,
- •Easily visualized uvula,
- •Not a current tobacco user
- •No history of alcohol abuse/must abstain from alcohol use 24 hours prior to and 24 hours after participation.
- •Ability to sign informed consent.
- •Able to pass standard MRI safety screening
- •Must have a responsible adult available to transport subject home safely after end of experiment.
排除标准
- •Healthy male or females less than 20 years of age or older than 40 years of age
- •Any physical signs suggestive of difficult airway (mouth opening 3cm, short distance between the chin and neck, poor mandibular subluxation, thick neck),
- •History of obstructive sleep apnea,
- •History of asthma
- •Neuropsychiatric disorders,
- •History of, or current use of psychotropic medications,
- •Current tobacco use or history of smoking in past month
- •Alcohol use exceeding 2 drinks/day
- •History of hypertension or current medication for blood pressure control,
- •Cardiovascular disease or arrhythmias,
- •Positive urine toxicology screen,
- •History of gastroesophageal reflux disease,
- •Sleep disorders,
- •History of postoperative nausea/vomiting or motion sickness,
- •Inability to sign informed consent
- •Contraindications for safely participating in MRI imaging study,
- •Does not have a responsible adult available to provide transport from HUP MRI area to home.
研究组 & 干预措施
Brain connectivity and physiology
Dexmedetomidine anesthesia on glymphatic flow in human subjects as visualized by diffusion tensor MRI.
干预措施: Brain connectivity and physiology (Other)
Brain connectivity and physiology
Dexmedetomidine anesthesia on glymphatic flow in human subjects as visualized by diffusion tensor MRI.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Glymphatic clearance from the human brain
时间窗: 2 hours
Assessment of the effect of dexmedetomidine anesthesia on glymphatic flow in subjects as visualized by diffusion tensor MRI.
次要结局
未报告次要终点