RecruitingNot ApplicableNCT06003127

REcovery From DEXmedetomidine-induced Unconsciousness

Sponsor

Massachusetts General Hospital

Enrollment

12 participants

Start Date

Nov 15, 2024

Study Type

INTERVENTIONAL

Conditions

Anesthesia Healthy Consciousness, Level Altered

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria7

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 Criteria14

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).