REcovery From DEXmedetomidine-induced Unconsciousness

Launched by MASSACHUSETTS GENERAL HOSPITAL · Aug 18, 2023

Keywords

ClinConnect Summary

This clinical trial, titled "REcovery from DEXmedetomidine-induced Unconsciousness," is looking to understand how biological sex might affect recovery from a medication called dexmedetomidine, which can cause temporary unconsciousness. The study also aims to explore a special technique using transcranial magnetic stimulation and electroencephalography (TMS-EEG) to measure brain activity during sedation without waking the participants up. This research is being conducted with healthy volunteers aged 18 to 65.

To participate, individuals must be non-smokers with a normal body weight and not have any serious health issues, such as neurological or psychiatric disorders, heart problems, or certain other medical conditions. Participants should expect to undergo sedation with dexmedetomidine and have their brain activity monitored during the process. The study is currently recruiting volunteers, and being fluent in English is important for understanding the instructions and consent forms. If you think you might be eligible and are interested in participating, it could be a valuable opportunity to contribute to understanding recovery from sedation.

Gender

ALL

Eligibility criteria

• 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 standard drug screening test (toxicology).