Recruiting

Dexmedetomidine

Sponsor:

Massachusetts General Hospital

Code:

NCT06003127

Conditions

Anesthesia

Healthy

Consciousness, Level Altered

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Transcranial Magnetic Stimulation-Electroencephalography

Study Details

Brief 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.

Conditions

Anesthesia

Healthy

Consciousness, Level Altered

Study ID

NCT06003127

Start date

Nov 15, 2024

Status verified date

Jan, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

12 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: TMS-EEG Arm

This arm will undergo TMS-EEG during the study.

no intervention: Non-TMS-EEG Arm

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

Interventions

Transcranial Magnetic Stimulation-Electroencephalography

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

Primary outcome measure

  • Time to return of responsiveness [ Time Frame: Up to 120 minutes ]

Central Contacts and Locations

Central contacts

Emery N Brown, MD, PhD

+1 617-324-1879ebrown@mgh.harvard.edu

David Schreier, MD, PhD

dschreier@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Emery N Brown, MD, PhD

617-324-1879ebrown@mgh.harvard.edu

David Schreier, MD, PhD

dschreier@mgh.harvard.edu

Principal Investigator:

Emery N Brown, MD, PhD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jan 22, 2026

Last verified

Jan, 2026

Keywords

  • Dexmedetomidine
  • EEG
  • Transcranial magnetic stimulation
  • Cognition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-01-22.