REcovery from DEXmedetomidine-induced Unconsciousness
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
- Anesthesia
- Healthy
- Consciousness, Level Altered
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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental TMS-EEG Arm |
This arm will undergo TMS-EEG during the study. |
|
|
No Intervention Non-TMS-EEG Arm |
This arm will not undergo TMS-EEG during the study. |
|
Recruiting Locations
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital