Anesthesia, Consciousness, Level Altered, Healthy
Conditions
Keywords
Dexmedetomidine, EEG, Transcranial magnetic stimulation, Cognition
Brief summary
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.
Interventions
DEVICETranscranial Magnetic Stimulation-Electroencephalography
Transcranial magnetic stimulation of the cerebral cortex and measurement of TMS-evoked potentials in the EEG.
Sponsors
Massachusetts General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to return of responsiveness | 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. |
Countries
United States
Contacts
CONTACTEmery N Brown, MD, PhD
CONTACTDavid Schreier, MD, PhD
PRINCIPAL_INVESTIGATOREmery N Brown, MD, PhD
Massachusetts General Hospital
Outcome results
None listed