REcovery From DEXmedetomidine-induced Unconsciousness

NCT06003127 | Recruiting FDA Device

• 1 other identifier: 2023P001821
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

Dexmedetomidine; EEG; Transcranial magnetic stimulation; Cognition

Outcome Measures

Primary Outcomes (1)

• Time to return of responsiveness

  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.

  Up to 120 minutes

Study Arms (2)

TMS-EEG Arm

EXPERIMENTAL

This arm will undergo TMS-EEG during the study.

Device: Transcranial Magnetic Stimulation-Electroencephalography

Non-TMS-EEG Arm

NO INTERVENTION

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

Interventions

Transcranial Magnetic Stimulation-Electroencephalography DEVICE

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

Also known as: TMS-EEG

TMS-EEG Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 37142466 BACKGROUND

• 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.

  PMID: 34084141 BACKGROUND

MeSH Terms

Conditions

Consciousness Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Emery N Brown, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emery N Brown, MD, PhD

CONTACT

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

David Schreier, MD, PhD

CONTACT

dschreier@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 21, 2023
• Study Start: November 15, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

US (1)