Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06003127

REcovery From DEXmedetomidine-induced Unconsciousness

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

David Schreier, MD, PhD

CONTACT

[email protected]

Emery N Brown, MD, PhD

CONTACT

[email protected]

617-324-1879

Emery N Brown, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Transcranial Magnetic Stimulation-Electroencephalography

Device

Transcranial magnetic stimulation of the cerebral cortex and measurement of TMS-evoked potentials in the EEG.

Other names: TMS-EEG

Primary outcomes

  1. Time to return of responsiveness

    Time frame: Up to 120 minutes

    The time to return of responsiveness will be measured in minutes and from the moment of dexmedetomidine discontinuation to the return of clicking a button in response to auditory stimulation.

Study contacts

Contact information is provided by the study sponsor or research team.

David Schreier, MD, PhD

CONTACT

[email protected]

Emery N Brown, MD, PhD

CONTACT

[email protected]

+1 617-324-1879

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Acronym: REDEX

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2023
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.