REcovery From DEXmedetomidine-induced Unconsciousness

NCT ID: NCT06003127

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-15
• Study Completion Date: 2026-12-31

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 Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

TMS-EEG Arm

This arm will undergo TMS-EEG during the study.

Group Type: EXPERIMENTAL

Transcranial Magnetic Stimulation-Electroencephalography

Intervention Type: DEVICE

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

Non-TMS-EEG Arm

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Transcranial Magnetic Stimulation-Electroencephalography

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

Intervention Type: DEVICE

Other Intervention Names

TMS-EEG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Emery Brown

Professor of Anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emery N Brown, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Emery N Brown, MD, PhD

Role: CONTACT

ebrown@mgh.harvard.edu

+1 617-324-1879

David Schreier, MD, PhD

Role: CONTACT

dschreier@mgh.harvard.edu

Facility Contacts

Emery N Brown, MD, PhD

Role: primary

ebrown@mgh.harvard.edu

617-324-1879

David Schreier, MD, PhD

Role: backup

dschreier@mgh.harvard.edu

References

Vincent KF, Mallari OG, Dillon EJ, Stewart VG, Cho AJ, Dong Y, Edlow AG, Ichinose F, Xie Z, Solt K. Oestrous cycle affects emergence from anaesthesia with dexmedetomidine, but not propofol, isoflurane, or sevoflurane, in female rats. Br J Anaesth. 2023 Jul;131(1):67-78. doi: 10.1016/j.bja.2023.03.025. Epub 2023 May 2.

Reference Type: BACKGROUND

PMID: 37142466 (View on PubMed)

Kato R, Zhang ER, Mallari OG, Moody OA, Vincent KF, Melonakos ED, Siegmann MJ, Nehs CJ, Houle TT, Akeju O, Solt K. D-Amphetamine Rapidly Reverses Dexmedetomidine-Induced Unconsciousness in Rats. Front Pharmacol. 2021 May 18;12:668285. doi: 10.3389/fphar.2021.668285. eCollection 2021.

Reference Type: BACKGROUND

PMID: 34084141 (View on PubMed)

Other Identifiers

2023P001821

Identifier Type: -

Identifier Source: org_study_id