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The investigators are doing this research study to find out how and where dexmedetomidine, a sedative anesthetic, acts in the brain. The investigators will do this by using a machine that records the brains electrical activity, called an electroencephalogram (EEG), and brain imaging scans to look at the brain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active study arm | Experimental | Subjects recruited into this study will be required to undergo two magnetic resonance imaging- positron emission tomography (MRI-PET) scans of the brain in addition to high density electroencephalogram (EEG) acquisition. The first scan will be a baseline scan while the second scan will be performed while dexmedetomidine is being infused. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexmedetomidine | Drug | The dexmedetomidine infusion will be individualized to each study participant by a target plasma concentration where loss of consciousness is initially observed. Loss of consciousness will be assayed by specific auditory and verbal stimuli. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Changes in the Brains Default Mode Network. | Number of participants with changes in the Default Mode network during loss and recovery of consciousness under dexmedetomidine induced sedation versus baseline as assessed by changes in blood oxygen level depended (BOLD) signals during the awake, unconscious, and recovery states. | 1.5hrs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oluwaseun Johnson-Akeju, M.D | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Study Arm | Subjects recruited into this study will be required to undergo two magnetic resonance imaging-positron emission tomography scans of the brain in addition to high density electroencephalogram acquisition. The first scan will be a baseline scan while the second scan will be performed while dexmedetomidine is being infused. dexmedetomidine: The dexmedetomidine infusion will be individualized to each study participant by a target plasma concentration where loss of consciousness is initially observed. Loss of consciousness will be assayed by specific auditory and verbal stimuli. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Study Arm | Subjects recruited into this study will be required to undergo two MRI-PET scans of the brain in addition to high density electroencephalogram acquisition. The first scan will be a baseline scan while the second scan will be performed while dexmedetomidine is being infused. dexmedetomidine: The dexmedetomidine infusion will be individualized to each study participant by a target plasma concentration where loss of consciousness is initially observed. Loss of consciousness will be assayed by specific auditory and verbal stimuli. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Changes in the Brains Default Mode Network. | Number of participants with changes in the Default Mode network during loss and recovery of consciousness under dexmedetomidine induced sedation versus baseline as assessed by changes in blood oxygen level depended (BOLD) signals during the awake, unconscious, and recovery states. | All 17 participants were analyzed. Blood oxygen level depended (BOLD) signals during the awake (n = 16), unconscious (n = 16), and recovery (n = 15) states were included in the final data set. | Posted | Number | participants | 1.5hrs |
|
Adverse events were collected during the entire duration of the study.
Adverse events were systematically characterized according to our research protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Study Arm | Subjects recruited into this study will be required to undergo two MR-PET scans of the brain in addition to high density EEG acquisition. The first scan will be a baseline scan while the second scan will be performed while dexmedetomidine is being infused. dexmedetomidine: The dexmedetomidine infusion will be individualized to each study participant by a target plasma concentration where loss of consciousness is initially observed. Loss of consciousness will be assayed by specific auditory and verbal stimuli. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Oluwaseun Johnson-Akeju | Massachusetts General Hospital | 6177247200 | oluwaseun.akeju@mgh.harvard.edu |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| 0 |
| 20 |
| 0 |
| 20 |
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