REcovery From DEXmedetomidine-induced Unconsciousness

Study Overview
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Brief Summary
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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.

Official Title
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REcovery From DEXmedetomidine-induced Unconsciousness

Conditions
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Consciousness, Level Altered, Anesthesia, Healthy

Intervention / Treatment
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* Device: Transcranial Magnetic Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between the ages of 18 to 45 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: use of hormonal contraception 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 drug test that screens for the following: Cocaine (COC), d-Amphetamine (AMP), d-Methamphetamine (Mamp), Tetrahydrocannabinol (THC), Methadone (MTD), Opiates (OPI), Phencyclidine (PCP), Barbiturates (BAR), Benzodiazepines (BZO), Oxycodone (OXY)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcranial Magnetic Stimulation (TMS) Arm<br>This arm will undergo TMS during the study. | Device: Transcranial Magnetic Stimulation<br>* Repetitive transcranial magnetic stimulation and measurement of related evoked potentials in the EEG.<br>* Other names: TMS-EEG;|
| No Intervention: Non-Transcranial Magnetic Stimulation (TMS) Arm<br>This arm will not undergo TMS during the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to return of responsiveness | The time to return of responsiveness will be measured in minutes and from the moment of dexmedetomidine discontinuation to the return of hand squeezing (five times in a row) in response to auditory stimulation. | Up to 120 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EEG, Dexmedetomidine, Transcranial magnetic stimulation, Cognition