REcovery from DEXmedetomidine-induced Unconsciousness

Not Applicable

Recruiting

• Conditions: Consciousness, Level Altered; Healthy; Anesthesia
• Interventions: Device: Transcranial Magnetic Stimulation

• Registration Number: NCT06003127
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-10
• Study First Submitted QC: 2023-08-18
• Study First Posted: 2023-08-21
• Study Start: 2024-11-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-20
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TMS-EEG Arm	Transcranial Magnetic Stimulation	This arm will undergo TMS-EEG during the study.

Primary Outcome Measures

Name	Time	Method
Time to return of responsiveness	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States