RecruitingNot ApplicableNCT06003127
REcovery From DEXmedetomidine-induced Unconsciousness
Sponsor
Massachusetts General Hospital
Enrollment
12 participants
Start Date
Nov 15, 2024
Study Type
INTERVENTIONAL
Conditions
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).
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Interventions
DEVICETranscranial Magnetic Stimulation-Electroencephalography
Transcranial magnetic stimulation of the cerebral cortex and measurement of TMS-evoked potentials in the EEG.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06003127
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