REcovery From DEXmedetomidine-induced Unconsciousness

Last updated: June 13, 2025
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Anesthesia

Treatment

Transcranial Magnetic Stimulation-Electroencephalography

Transcranial Magnetic Stimulation

Clinical Study ID

NCT06003127
2023P001821
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

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 lastmenstrual 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 theconsent form)

Exclusion

Exclusion Criteria:

  • Neurologic: epilepsy or positive history of a seizure, stroke, central disorders ofhypersomnolence, neuroimmunological disorder (e.g. multiple sclerosis), Meniere'sdisease, Parkinson's disease, peripheral neuropathy, no significant visual orhearing impairments, findings in the clinical examination suggesting a neurologicdisorder

  • Psychiatric: history or treatment for an active psychiatric problem (includingAttention-Deficit / Hyperactivity Disorder (ADHD) and anxiety disorder)

  • Cardiovascular: hypertension, symptomatic hypotension or bradycardia, myocardialinfarction, coronary artery disease, peripheral vascular disease, dysrhythmias,congestive heart failure, cardiomyopathy, valvular disease, familial history ofsudden 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, personalor family history of malignant hyperthermia

  • Medications: regular use of prescription and non-prescription medications expectedto affect central nervous function, anticoagulant or thrombocyte-aggregationinhibiting therapy; exception: oral hormonal contraception

  • Allergies: dexmedetomidine, phenylephrine, betablockers (including labetalol andesmolol), hydralazine, glycopyrrolate

Potential participants will not be enrolled in our study if they fail to pass a standard drug screening test (toxicology).

Study Design

Total Participants: 12
Treatment Group(s): 2
Primary Treatment: Transcranial Magnetic Stimulation-Electroencephalography
Phase:
Study Start date:
November 15, 2024
Estimated Completion Date:
February 28, 2026

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

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