Assessing Covert Consciousness During Dexmedetomidine and Ketamine Sedation: An fMRI Study
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Blood Oxygen Level Dependent (BOLD) response to mental imagery tasks
研究概览
简要总结
This research is studying whether mental functions take place during different levels of anesthesia, using a commonly used drug (either dexmedetomidine [with propofol in some participants] or ketamine), which shows areas in the brain involved in thinking at different depths of anesthesia. As a result of this study, the researchers expect to gain a deeper understanding of mental function during different levels of anesthesia.
详细描述
Dexmedetomidine is an FDA-approved sedative agent and is used off-label in this study for controlled experimental modulation of consciousness under direct anesthesiology supervision. Ketamine is a FDA-approved anesthetic and analgesic agent and is used off-label in this study for controlled experimental modulation of consciousness under direct anesthesiology supervision.
Using fMRI and established cognitive paradigms, the proposed study will directly examine residual conscious processing under dexmedetomidine and ketamine and compare these findings with our existing propofol dataset from NCT03361605.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
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
- •Healthy study subjects with American Society of Anesthesiologists (ASA)-1 status
- •Right-handed
- •Body mass index (BMI) less than 30
- •Participants will have the experience of playing tennis (or other racquet sport) at least 30 times in their lifetime
- •English speaking
排除标准
- •Medical contraindication to MRI scanning; are unable to undergo MRI scanning because of possible pregnancy or currently breastfeeding
- •BMI greater than or equal to 30
- •Metallic substances in the body
- •claustrophobia, anxiety, or cardiopulmonary disease; or have an intracranial structural abnormality on T1-weighted MRI scans
- •history of allergy to dexmedetomidine, ketamine, propofol, or any components of these medications, eggs or egg products, soybean or soybean products
- •neurological, cardiovascular, or pulmonary illness
- •significant head injury with loss of consciousness; learning disability or other developmental disorder
- •sleep apnea or any severe snoring history
- •gastroesophageal reflux disease (GERD) or heartburn; pancreatitis or a history of pancreatitis,
- •sensory/motor loss sufficient to interfere with performance of the study
- •epilepsy/seizure disorder (including a history of seizures) or stroke (including a history of stroke).
- •history of schizophrenia spectrum disorder, bipolar disorder, other psychotic disorder, or any prior adverse psychiatric reaction to ketamine or similar drugs
- •Participants taking medications that, in the judgment of the investigators or attending anesthesiologist, may interact with the study drugs or increase the risk of participation will also be excluded
- •participants with hypertension or diabetes mellitus
- •tattoos in the head or neck region will be excluded from study; other tattoos are subject to determination by investigators based on their assessment regarding participant safety
- •recent food or liquid intake (within 8 hours)
- •history of drug use, have a positive drug screen, are unwilling to abstain from alcohol for 24 hours prior to dosing, or have a current history of nicotine use.
- •Potential participants who have participated in a clinical trial using an investigational drug or device within 30 days will be considered for enrollment after 30 days.
- •History of a difficult airway with a previous anesthetic
研究组 & 干预措施
Dexmedetomidine during fMRI
About 30 healthy participants will be randomized to this arm.
干预措施: Dexmedetomidine (+propofol as indicated) (Drug)
Ketamine during fMRI
About 30 healthy participants will be randomized to this arm.
干预措施: Ketamine (Drug)
结局指标
主要结局
Blood Oxygen Level Dependent (BOLD) response to mental imagery tasks
时间窗: Up to approximately 130 minutes
Three mental imagery tasks will be used: tennis imagery, navigation imagery, and hand-squeeze imagery
次要结局
- Grip force (in mmHg) of participants' hand squeezing on a rubber ball in response to squeeze instructions(Up to approximately 130 minutes)
研究者
Zirui Huang
Research Assistant Professor of Anesthesiology and Director of Center for Consciousness Science
University of Michigan