REcovery From DEXmedetomidine-induced Unconsciousness
Recruiting
N/AInterventional Study
AnesthesiaHealthyConsciousness, Level Altered
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Study type
Interventional
Purpose
Basic Science
Participants needed
12 (estimated)
Sponsor
Massachusetts General Hospital · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
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Eligibility Criteria
Inclusion Criteria:
* 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 ag…
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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).
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