REcovery From DEXmedetomidine-induced Unconsciousness (REDEX)

Mass General Brigham

Status: Enrolling

Conditions: Healthy; Consciousness, Level Altered; Anesthesia

Treatments: Device: Transcranial Magnetic Stimulation-Electroencephalography

Study type: Interventional

Funder types: Other

Identifiers

NCT06003127

2023P001821

Details and patient eligibility

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

TMS-EEG Arm

Experimental group

Description:

This arm will undergo TMS-EEG during the study.

Treatment:

Device: Transcranial Magnetic Stimulation-Electroencephalography

Non-TMS-EEG Arm

No Intervention group

Description:

This arm will not undergo TMS-EEG during the study.