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| Name | Class |
|---|---|
| Boston University | OTHER |
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The investigators will be studying the sedative drug dexmedetomidine using hybrid PET/fMRI/EEG imaging to better understand the neuropharmacology of anesthesia/artificially induced sleep.
A group of healthy volunteers will undergo simultaneous PET/fMRI/EEG imaging under two different conditions: while being administered a sedative (dexmedetomidine), and while being administered a normal saline infusion, as a control. The order of these two scans will be randomized, and the study design is open label (ie subjects and investigators know which session will be the control scan and which one will be the sedative scan). Investigators hope that by comparing the results of the sedative and control scans, the different neuromodulatory states involved in the transition from wakefulness to medically induced vs naturally occurring sleep can be better understood.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine | Experimental | During the imaging scan subjects will receive an initial 1µg/kg bolus of dexmedetomidine up to a maximum dose of 80 µg, infused through IV over 10 minutes. After the bolus has been administered, a constant infusion of up to 0.6 µg/kg/hr (0.01 µg/kg/min) of dexmedetomidine will be maintained for the remainder of the scan (about 60 minutes). |
|
| Saline | Placebo Comparator | A saline infusion will be used as a placebo comparator for the dexmedetomidine infusion. It will be administered in the same manner and dosages as the dexmedetomidine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | During the imaging scan subjects will receive an initial bolus of dexmedetomidine over 10 minutes. After the bolus has been administered, a constant infusion of dexmedetomidine will be maintained for the remainder of the scan (about 60 minutes). |
| Measure | Description | Time Frame |
|---|---|---|
| Brain positron emission tomography (PET) imaging signals. | Changes in dopamine receptor availability will be quantified from brain PET images. | 2 hours |
| Functional magnetic resonance imaging (fMRI) signals. | fMRI measures of hemodynamic responses. | 2 hours |
| Differences in electroencephalography (EEG) measures between arousal and anesthesia. | Arousal states will be characterized from changes in the EEG power spectrum. | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate | Heart rate variability. | 2 hours |
| Pulse oximetry | Amplitude of pulse oximetry signal. | 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Irena Bass, BA | Contact | 617-726-9034 | ibass@mgh.harvard.edu | |
| Christin Y Sander, PhD | Contact | 617-726-9034 | csander@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Christin Y Sander, PhD | Athinoula A. Martinos Center for Biomedical Imaging | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Athinoula A. Martinos Center for Biomedical Imaging | Recruiting | Charlestown | Massachusetts | 02129 | United States |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Saline | Drug | During the imaging scan subjects will receive an initial bolus of saline over 10 minutes. After the bolus has been administered, a constant infusion of saline will be maintained for the remainder of the scan (about 60 minutes). |
|
| Respiratory physiology | Breathing rate (breaths per minute). | 2 hours |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |