Status:
RECRUITING
REcovery From DEXmedetomidine-induced Unconsciousness
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Anesthesia
Healthy
Eligibility:
All Genders
18-65 years
Phase:
NA
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
November 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06003127
Start Date
November 15 2024
End Date
February 1 2026
Last Update
June 17 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114