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REDEX: REcovery From DEXmedetomidine-induced Unconsciousness

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06003127
Collaborator
(none)
12
Enrollment
2
Arms
6
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Transcranial Magnetic Stimulation
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
REcovery From DEXmedetomidine-induced Unconsciousness
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Transcranial Magnetic Stimulation (TMS) Arm

This arm will undergo TMS during the study.

Device: Transcranial Magnetic Stimulation
Repetitive transcranial magnetic stimulation and measurement of related evoked potentials in the EEG.
Other Names:
  • TMS-EEG

    		•
    No Intervention: Non-Transcranial Magnetic Stimulation (TMS) Arm

    This arm will not undergo TMS during the study.

    Outcome Measures

    Primary Outcome Measures

    1. 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 hand squeezing (five times in a row) in response to auditory stimulation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Between the ages of 18 to 45

    • 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: use of hormonal contraception

    • 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 drug test that screens for the following: Cocaine (COC), d-Amphetamine (AMP), d-Methamphetamine (Mamp), Tetrahydrocannabinol (THC), Methadone (MTD), Opiates (OPI), Phencyclidine (PCP), Barbiturates (BAR), Benzodiazepines (BZO), Oxycodone (OXY)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Massachusetts General Hospital

    Investigators

    • Principal Investigator: Ken Solt, MD, Massachusetts General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ken Solt, Associate Professor of Anesthesia, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT06003127
    Other Study ID Numbers:
    • 2023P001821
    First Posted:
    Aug 21, 2023
    Last Update Posted:
    Aug 21, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Ken Solt, Associate Professor of Anesthesia, Massachusetts General Hospital
    Dexmedetomidine
    EEG
    Transcranial magnetic stimulation
    Cognition
    Additional relevant MeSH terms:
    Unconsciousness
    Consciousness Disorders

    Study Results

    No Results Posted as of Aug 21, 2023