REcovery from DEXmedetomidine-induced Unconsciousness

Description

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.

Conditions

Anesthesia, Healthy, Consciousness, Level Altered

Study Overview

Study Details

Study overview

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.

REcovery from DEXmedetomidine-induced Unconsciousness

REcovery from DEXmedetomidine-induced Unconsciousness

Condition
Anesthesia
Intervention / Treatment

-

Contacts and Locations

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Massachusetts General Hospital,

Ken Solt, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

2025-05