Ketamine and Propofol NeuroImaging
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Explicit Memory Performance, comparing single-drug to drug-combination condition
研究概览
简要总结
This is a multi-visit which will collect MRI (pictures of the brain) and EEG (brain waves) data to determine changes in brain connectivity and brain activity for memory formation and pain perception while receiving the commonly-used anesthetic agents ketamine and propofol, both alone and in combination.
详细描述
There are four independent drug-administration sessions, visits 1, 3, 5, and 7. In all four of these sessions, both drugs are received, but in two different sequences. Two of these are EEG sessions and two are MRI sessions. Both EEG and MRI will have the same two drug orderings:
- Propofol alone, followed by ketamine and propofol together
- Ketamine alone, followed by propofol and ketamine together Assignment to propofol alone first, versus ketamine alone first will be randomized. But, all subjects will be assigned to receive both drug orderings under both EEG monitoring and MRI acquisition.
A follow-up memory testing visit will occur the day after each MRI/EEG session, on visits 2, 4, 6, and 8. No drugs are given during the next-day testing sessions.
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
- Single (Participant)
盲法说明
Participants are not informed which agent is being administered first, but do know they will receive both in each drug session.
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 18-59 years of age, who:
- •have none of the specific
排除标准
- •have a valid email address and valid phone number throughout the study
- •free from any non-MRI compatible implants
- •Exclusion Criteria:
- •are pregnant or attempting to conceive
- •body mass index (BMI) > 35
- •significant memory impairment or hearing loss
- •sleep apnea
- •chronic pain or frequently taking pain medication
- •chronic medical conditions requiring treatment (hypertension, diabetes, high cholesterol)
- •neurologic disease, including seizures and tremor
- •psychiatric diagnoses, including anxiety, depression, panic, or PTSD
- •a history of any of these medical conditions: abnormal heartbeats (cardiac conduction abnormality or arrhythmia), liver or kidney disease, or significant lung disease
- •severe claustrophobia or intolerance of an MRI
- •have metal implants or non-removable metal piercings
- •having a history of adverse reaction to ketamine or propofol
- •daily alcohol or heavy alcohol use; history of alcohol abuse
- •current daily smoker
- •regular or recent marijuana use (including prescribed/medical marijuana)
- •illicit drug use, i.e., street drugs
- •regularly taking: antiepileptics, antidepressants, anti-psychotics, antihistamines, anti-anxiety medication, stimulants, or sleep-aids
研究组 & 干预措施
Propofol, followed by propofol+ketamine (given at first visit)
- Propofol, followed by propofol+ketamine at Visit 1
- Ketamine, followed by ketamine+propofol at Visit 3
- Propofol, followed by propofol+ketamine at Visit 5
- Ketamine, followed by ketamine+propofol at Visit 7
EEG will be done at either visits 1 and 3 or 5 and 7; fMRI will be done at the other two (non-EEG) visits.
干预措施: Peripheral Nerve Stimulation (Device)
Ketamine, followed by ketamine+propofol (given at first visit)
- Ketamine, followed by ketamine+propofol at Visit 1
- Propofol, followed by propofol+ketamine at Visit 3
- Ketamine, followed by ketamine+propofol at Visit 5
- Propofol, followed by propofol+ketamine at Visit 7
EEG will be done at either visits 1 and 3 or 5 and 7; fMRI will be done at the other two (non-EEG) visits.
干预措施: Peripheral Nerve Stimulation (Device)
Propofol, followed by propofol+ketamine (given at first visit)
- Propofol, followed by propofol+ketamine at Visit 1
- Ketamine, followed by ketamine+propofol at Visit 3
- Propofol, followed by propofol+ketamine at Visit 5
- Ketamine, followed by ketamine+propofol at Visit 7
EEG will be done at either visits 1 and 3 or 5 and 7; fMRI will be done at the other two (non-EEG) visits.
干预措施: Propofol (Drug)
Propofol, followed by propofol+ketamine (given at first visit)
- Propofol, followed by propofol+ketamine at Visit 1
- Ketamine, followed by ketamine+propofol at Visit 3
- Propofol, followed by propofol+ketamine at Visit 5
- Ketamine, followed by ketamine+propofol at Visit 7
EEG will be done at either visits 1 and 3 or 5 and 7; fMRI will be done at the other two (non-EEG) visits.
干预措施: Ketamine (Drug)
Ketamine, followed by ketamine+propofol (given at first visit)
- Ketamine, followed by ketamine+propofol at Visit 1
- Propofol, followed by propofol+ketamine at Visit 3
- Ketamine, followed by ketamine+propofol at Visit 5
- Propofol, followed by propofol+ketamine at Visit 7
EEG will be done at either visits 1 and 3 or 5 and 7; fMRI will be done at the other two (non-EEG) visits.
干预措施: Propofol (Drug)
Ketamine, followed by ketamine+propofol (given at first visit)
- Ketamine, followed by ketamine+propofol at Visit 1
- Propofol, followed by propofol+ketamine at Visit 3
- Ketamine, followed by ketamine+propofol at Visit 5
- Propofol, followed by propofol+ketamine at Visit 7
EEG will be done at either visits 1 and 3 or 5 and 7; fMRI will be done at the other two (non-EEG) visits.
干预措施: Ketamine (Drug)
结局指标
主要结局
Explicit Memory Performance, comparing single-drug to drug-combination condition
时间窗: Visits 2, 4, 6, and 8. Visits spaced at least 1 week apart, are 1 hour in length, and are 12-36 hours after the preceding visit (1, 3, 5, and 7).
Recognition memory testing, using the Remember-Know procedure, in which subjects indicate whether they recognize previously experienced experimental items among novel items (not previously in the experiment). This allows calculation of interdependent measures of recollection \& familiarity using the signal detection statistic, d'. d' is calculated as the cumulative Gaussian distribution of false positive responses subtracted from the cumulative Gaussian distribution of correctly identified previously-experienced items. d' is on a (theoretically infinite) scale of standard deviation units, with negative values representing performance worse than chance guessing and positive values representing stand deviations of performance above chance.
Pain intensity and unpleasantness ratings, comparing single-drug to drug-combination condition
时间窗: Visits 1, 3, 5, and 7: immediately following each experimental condition. These visits are 3 hours in length and spaced at least 1 week apart.
Numerical rating scale (0-10) pain score difference, comparing the single-drug condition to the steady-state dose of the drug-combination condition. Higher pain scores indicate more pain; a positive difference between pain scores during the single-drug condition minus the value during the steady-state dose of the combination-drug condition indicates pain reduction (a better outcome).
次要结局
- MRI-based activation during memory formation, comparing the single-drug condition to the combination-drug condition(MRI visits (1 and 3, or 5 and 7), which are are 3 hours in length and spaced at least 1 week apart. Data collected at 3 timepoints in 8-minute MRI scans: at baseline, under one drug, and under both drugs.)
- MRI-based activation during painful stimulation, comparing the single-drug condition to the combination-drug condition(MRI visits (1 and 3, or 5 and 7), which are are 3 hours in length and spaced at least 1 week apart. Data collected at 3 timepoints in 8-minute MRI scans: at baseline, under one drug, and under both drugs.)
- MRI-based changes in functional connectivity, comparing the single-drug condition to the combination-drug condition(MRI visits (1 and 3, or 5 and 7), which are are 3 hours in length and spaced at least 1 week apart. Data collected at 3 timepoints in 8-minute MRI scans: at baseline, under one drug, and under both drugs.)
- EEG-based changes in functional connectivity, comparing single-drug to combination-drug condition.(EEG visits (1 and 3, or 5 and 7), which are are 3 hours in length and spaced at least 1 week apart. Data collected at 3 timepoints in 8-minute EEG scans: at baseline, under one drug, and under both drugs.)
研究者
Keith M Vogt
Associate Professor
University of Pittsburgh