Actively Recruiting
REcovery From DEXmedetomidine-induced Unconsciousness
Led by Massachusetts General Hospital · Updated on 2026-01-22
12
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
REcovery From DEXmedetomidine-induced Unconsciousness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 older than 45 years with last menstrual period over 12 months ago without contraceptives
- American Society of Anesthesiologists (ASA) physical status classification 1 (ASA 1)
- Fluent in English to communicate with the study team and understand consent
You will not qualify if you...
- History or presence of neurologic conditions such as epilepsy, seizures, stroke, hypersomnolence disorders, neuroimmunological disorders, Meniere's disease, Parkinson's disease, peripheral neuropathy, or significant visual or hearing impairments
- Psychiatric history or current treatment for active psychiatric problems including ADHD or anxiety disorder
- Cardiovascular conditions including hypertension, symptomatic hypotension or bradycardia, myocardial infarction, coronary artery disease, peripheral vascular disease, dysrhythmias, congestive heart failure, cardiomyopathy, valvular disease, or family history of sudden cardiac death
- Respiratory conditions such as bronchitis, asthma, chronic obstructive pulmonary disease, smoking, shortness of breath, or sleep apnea
- Gastrointestinal problems including esophageal reflux, hiatal hernia, or ulcers
- Liver diseases such as hepatitis, jaundice, or ascites
- Severe acute or chronic renal insufficiency
- Pregnancy or breastfeeding
- Endocrine diseases including diabetes, thyroid disease, or adrenal gland disease
- Blood disorders like blood dyscrasias, anemia, or coagulopathies
- Musculoskeletal issues such as prior head, neck, or face surgery or trauma, arthritis, or personal/family history of malignant hyperthermia
- Regular use of medications affecting central nervous function or anticoagulant therapies, except oral hormonal contraception
- Allergies to dexmedetomidine, phenylephrine, beta blockers (including labetalol and esmolol), hydralazine, or glycopyrrolate
- Failure to pass a standard drug toxicology screening test
AI-Screening
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Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
E
Emery N Brown, MD, PhD
CONTACT
D
David Schreier, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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