REcovery From DEXmedetomidine-induced Unconsciousness (NCT06003127) | Clinical Trial Compass
RecruitingNot Applicable
REcovery From DEXmedetomidine-induced Unconsciousness
United States12 participantsStarted 2024-11-15
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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,…