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The Influence of Dexmedetomidine Hypnosis on Cerebrospinal Fluid (CSF) Volume, Brain Diffusion and 'Stiffness' Characteristics.

Primary Purpose

Cerebrospinal Fluid Pressure Increased

Status
Withdrawn
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Dexmedetomidine
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cerebrospinal Fluid Pressure Increased focused on measuring dexmedetomidine

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Healthy Males or females between 18 and 40 years of age. Determined to be American Society of Anesthesiologist (ASA) 1 subjects.
  2. Ability to provide written informed consent.

Exclusion Criteria:

  1. Subjects with potential difficult airway as determined by the anesthesiologist
  2. History of or family history of difficulty with anesthesia or sedation procedures
  3. Known intolerance to dexmedetomidine
  4. Body mass index >30
  5. Subjects with any of the following: narcolepsy, obstructive sleep apnea (OSA) and/or abnormal sleeping patterns (including but not limited to those who use a Continuous positive Airway Pressure (C-PAP) machine, sleeping during the day, using medication to fall asleep, subjects reporting snoring as determined by self- report using Snoring, Tiredness, Observed apnea, Blood pressure, Body mass index, Age, Neck circumference and Gender (STOP-BANG) questionnaire (i) for undiagnosed OSA (3 or more 'yes' answers will exclude) and/or medical history;
  6. Subjects with a history of restless leg syndrome as determined by self-report and/or medical history;
  7. Use, in the past two weeks, of psychoactive medications (four weeks for fluoxetine) or medications that may affect brain function (including but not limited to opioid analgesics, antidepressants, antipsychotics, benzodiazepines and barbiturates) as determined by self-report and/or medical history;
  8. Current or past Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnosis of a psychiatric disorder if it was severe enough to require the use of medications and or hospitalization to treat the condition.
  9. Major medical problems that can impact brain function (e.g., problems of the Central Nervous System including seizures and psychosis; cardiovascular disease including hypertension and arrhythmias; metabolic, autoimmune, endocrine disorders) as determined by self-report, medical history and/or clinical exam;
  10. Hepatic dysfunction or impairment as determined by subjects' self-reported history
  11. Head trauma with loss of consciousness for more than 60 minutes as determined by self-report and/or medical history;
  12. Positive urine test for controlled substances (cocaine, methamphetamine, amphetamines, opioids, cannabinoids, benzodiazepines and barbiturates) at the screening visit and at each visit of imaging study and neuropsychological assessment;
  13. Positive urine pregnancy test;
  14. Nursing mothers will be excluded
  15. Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head (including but not limited to pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, large tattoos, implanted delivery pump, or shrapnel fragments) or fear of enclosed spaces as determined by the self-report checklist.
  16. Fear of enclosed spaces (claustrophobia) as determined by self-report and medical history.
  17. Cannot lie comfortably flat on the back for up to 3 hours in the MRI scanner as determined by self- report.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Dexmedetomidine induced sleep patients

    Arm Description

    All subjects will be measured for CSF volume, diffusion parameters and mechanical 'stiffness' of the brain during wakefulness and during sleep-induced with dexmedetomidine (DEXM).

    Outcomes

    Primary Outcome Measures

    CSF volume increase by 10%
    We hypothesize that CSF volume (as measured by T1 relaxation) will expand by 10% with DEXM- induced sleep compared to wakefulness. The increase in CSF volume during DEXM-induced sleep occurs because DEXM lowers central norepinephrine tone and sleep causes an increase in the interstitial fluid (ISF) volume (cell volume shrinks). MRI will take place 30 minutes after dexmedetomidine infusion.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 27, 2018
    Last Updated
    May 24, 2022
    Sponsor
    Yale University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03757897
    Brief Title
    The Influence of Dexmedetomidine Hypnosis on Cerebrospinal Fluid (CSF) Volume, Brain Diffusion and 'Stiffness' Characteristics.
    Official Title
    The Influence of Dexmedetomidine Hypnosis on Cerebrospinal Fluid (CSF) Volume, Brain Diffusion and 'Stiffness' Characteristics
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The investigators were unable to implement a MRI compatible EEG for use in human subjects (equipment and technical issues).
    Study Start Date
    December 2021 (Anticipated)
    Primary Completion Date
    December 2022 (Anticipated)
    Study Completion Date
    December 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Yale University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The primary goal is to quantify cerebrospinal fluid (CSF) volume, diffusion characteristics and mechanical properties of brain tissue at two states of arousal.
    Detailed Description
    The primary goal is to quantify cerebrospinal fluid (CSF) volume, diffusion characteristics and mechanical properties of brain tissue at two states of arousal: Resting, awake state During sleep with low-dose intravenous infusion of dexmedetomidine (titrated to a Bispectral index (BIS) of 60-70)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebrospinal Fluid Pressure Increased
    Keywords
    dexmedetomidine

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Model Description
    This is a preliminary interventional trial in which participants will serve as their own controls.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Dexmedetomidine induced sleep patients
    Arm Type
    Experimental
    Arm Description
    All subjects will be measured for CSF volume, diffusion parameters and mechanical 'stiffness' of the brain during wakefulness and during sleep-induced with dexmedetomidine (DEXM).
    Intervention Type
    Drug
    Intervention Name(s)
    Dexmedetomidine
    Other Intervention Name(s)
    DEXM
    Intervention Description
    The standard dosing of 1mcg/kg will be implemented over 10 minutes followed by a maintenance infusion of 0.2-1.0 titrated to a the target BIS (60-70) during the 20 minutes prior to MRI.
    Primary Outcome Measure Information:
    Title
    CSF volume increase by 10%
    Description
    We hypothesize that CSF volume (as measured by T1 relaxation) will expand by 10% with DEXM- induced sleep compared to wakefulness. The increase in CSF volume during DEXM-induced sleep occurs because DEXM lowers central norepinephrine tone and sleep causes an increase in the interstitial fluid (ISF) volume (cell volume shrinks). MRI will take place 30 minutes after dexmedetomidine infusion.
    Time Frame
    2 hours 30 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy Males or females between 18 and 40 years of age. Determined to be American Society of Anesthesiologist (ASA) 1 subjects. Ability to provide written informed consent. Exclusion Criteria: Subjects with potential difficult airway as determined by the anesthesiologist History of or family history of difficulty with anesthesia or sedation procedures Known intolerance to dexmedetomidine Body mass index >30 Subjects with any of the following: narcolepsy, obstructive sleep apnea (OSA) and/or abnormal sleeping patterns (including but not limited to those who use a Continuous positive Airway Pressure (C-PAP) machine, sleeping during the day, using medication to fall asleep, subjects reporting snoring as determined by self- report using Snoring, Tiredness, Observed apnea, Blood pressure, Body mass index, Age, Neck circumference and Gender (STOP-BANG) questionnaire (i) for undiagnosed OSA (3 or more 'yes' answers will exclude) and/or medical history; Subjects with a history of restless leg syndrome as determined by self-report and/or medical history; Use, in the past two weeks, of psychoactive medications (four weeks for fluoxetine) or medications that may affect brain function (including but not limited to opioid analgesics, antidepressants, antipsychotics, benzodiazepines and barbiturates) as determined by self-report and/or medical history; Current or past Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnosis of a psychiatric disorder if it was severe enough to require the use of medications and or hospitalization to treat the condition. Major medical problems that can impact brain function (e.g., problems of the Central Nervous System including seizures and psychosis; cardiovascular disease including hypertension and arrhythmias; metabolic, autoimmune, endocrine disorders) as determined by self-report, medical history and/or clinical exam; Hepatic dysfunction or impairment as determined by subjects' self-reported history Head trauma with loss of consciousness for more than 60 minutes as determined by self-report and/or medical history; Positive urine test for controlled substances (cocaine, methamphetamine, amphetamines, opioids, cannabinoids, benzodiazepines and barbiturates) at the screening visit and at each visit of imaging study and neuropsychological assessment; Positive urine pregnancy test; Nursing mothers will be excluded Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head (including but not limited to pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, large tattoos, implanted delivery pump, or shrapnel fragments) or fear of enclosed spaces as determined by the self-report checklist. Fear of enclosed spaces (claustrophobia) as determined by self-report and medical history. Cannot lie comfortably flat on the back for up to 3 hours in the MRI scanner as determined by self- report.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Helene Benveniste, MD, PhD
    Organizational Affiliation
    Yale University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    The Influence of Dexmedetomidine Hypnosis on Cerebrospinal Fluid (CSF) Volume, Brain Diffusion and 'Stiffness' Characteristics.

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