Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts 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 drug test that screens for the following: Cocaine (COC), d-Amphetamine (AMP), d-Methamphetamine (Mamp), Tetrahydrocannabinol (THC), Methadone (MTD), Opiates (OPI), Phencyclidine (PCP), Barbiturates (BAR), Benzodiazepines (BZO), Oxycodone (OXY)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
TMS-EEG Arm
This arm will undergo TMS-EEG during the study.
  • Device: Transcranial Magnetic Stimulation
    Repetitive transcranial magnetic stimulation and measurement of related evoked potentials in the EEG.
    Other names:
    • TMS-EEG
No Intervention
Non-TMS-EEG Arm
This arm will not undergo TMS-EEG during the study.

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Ken Solt, M.D.
617-726-4359
ksolt@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Ken Solt, MD
1-617-726-4359
ksolt@mgh.harvard.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.