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REcovery From DEXmedetomidine-induced Unconsciousness (REDEX)

Primary Purpose

Anesthesia, Healthy, Consciousness, Level Altered

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Anesthesia focused on measuring Dexmedetomidine, EEG, Transcranial magnetic stimulation, Cognition

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Transcranial Magnetic Stimulation (TMS) Arm

    Non-Transcranial Magnetic Stimulation (TMS) Arm

    Arm Description

    This arm will undergo TMS during the study.

    This arm will not undergo TMS during the study.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    August 10, 2023
    Last Updated
    August 18, 2023
    Sponsor
    Massachusetts General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06003127
    Brief Title
    REcovery From DEXmedetomidine-induced Unconsciousness
    Acronym
    REDEX
    Official Title
    REcovery From DEXmedetomidine-induced Unconsciousness
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    March 2024 (Anticipated)
    Study Completion Date
    March 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Massachusetts General Hospital

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anesthesia, Healthy, Consciousness, Level Altered
    Keywords
    Dexmedetomidine, EEG, Transcranial magnetic stimulation, Cognition

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    12 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Transcranial Magnetic Stimulation (TMS) Arm
    Arm Type
    Experimental
    Arm Description
    This arm will undergo TMS during the study.
    Arm Title
    Non-Transcranial Magnetic Stimulation (TMS) Arm
    Arm Type
    No Intervention
    Arm Description
    This arm will not undergo TMS during the study.
    Intervention Type
    Device
    Intervention Name(s)
    Transcranial Magnetic Stimulation
    Other Intervention Name(s)
    TMS-EEG
    Intervention Description
    Repetitive transcranial magnetic stimulation and measurement of related evoked potentials in the EEG.
    Primary Outcome Measure Information:
    Title
    Time to return of responsiveness
    Description
    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.
    Time Frame
    Up to 120 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ken Solt, MD
    Phone
    1-617-726-4359
    Email
    ksolt@mgh.harvard.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    David Schreier, MD, PhD
    Email
    dschreier@mgh.harvard.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ken Solt, MD
    Organizational Affiliation
    Massachusetts General Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    37142466
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    34084141
    Citation
    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.
    Results Reference
    background

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    REcovery From DEXmedetomidine-induced Unconsciousness

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