NCT06003127招募中不适用
REcovery From DEXmedetomidine-induced Unconsciousness
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Time to return of responsiveness
研究概览
简要总结
This pilot study in healthy volunteers aims to determine if biological sex has an impact on recovery from dexmedetomidine-induced unconsciousness, and if transcranial magnetic stimulation combined with electroencephalography (TMS-EEG) can be used to measure brain complexity during dexmedetomidine sedation without arousing study participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 18 to 65
- •Normal body weight and habitus, body mass index (BMI) 18 to 30 kg/m2
- •Non-smoker
- •No history of taking stimulants or substance abuse
- •For women: either use of hormonal contraception, or > 45 years old and last menstrual period > 12 months ago in the absence of any contraceptives.
- •American Society of Anesthesiologists (ASA) physical status classification 1 (ASA 1)
- •Fluent in English (sufficient to communicate with the study team and understand the consent form)
排除标准
- •Neurologic: epilepsy or positive history of a seizure, stroke, central disorders of hypersomnolence, neuroimmunological disorder (e.g. multiple sclerosis), Meniere's disease, Parkinson's disease, peripheral neuropathy, no significant visual or hearing impairments, findings in the clinical examination suggesting a neurologic disorder
- •Psychiatric: history or treatment for an active psychiatric problem (including Attention-Deficit / Hyperactivity Disorder (ADHD) and anxiety disorder)
- •Cardiovascular: hypertension, symptomatic hypotension or bradycardia, myocardial infarction, coronary artery disease, peripheral vascular disease, dysrhythmias, congestive heart failure, cardiomyopathy, valvular disease, familial history of sudden cardiac death
- •Respiratory: bronchitis, asthma, chronic obstructive pulmonary disease, smoking, shortness of breath, sleep apnea
- •Gastrointestinal: esophageal reflux, hiatal hernia, ulcer
- •Hepatic: hepatitis, jaundice, ascites
- •Renal: acute or chronic severe renal insufficiency
- •Reproductive: pregnancy, breast-feeding
- •Endocrine: diabetes, thyroid disease, adrenal gland disease
- •Hematologic: blood dyscrasias, anemia, coagulopathies
- •Musculoskeletal: prior surgery or trauma to head neck or face, arthritis, personal or family history of malignant hyperthermia
- •Medications: regular use of prescription and non-prescription medications expected to affect central nervous function, anticoagulant or thrombocyte-aggregation inhibiting therapy; exception: oral hormonal contraception
- •Allergies: dexmedetomidine, phenylephrine, betablockers (including labetalol and esmolol), hydralazine, glycopyrrolate
- •Potential participants will not be enrolled in our study if they fail to pass a standard drug screening test (toxicology).
结局指标
主要结局
Time to return of responsiveness
时间窗: Up to 120 minutes
The time to return of responsiveness will be measured in minutes and from the moment of dexmedetomidine discontinuation to the return of clicking a button in response to auditory stimulation.
次要结局
未报告次要终点
研究者
Emery Brown
Professor of Anesthesia
Massachusetts General Hospital
研究点 (2)
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