Combined Electroencephalogram, Magnetic Resonance Imaging-Positron Emission Tomography of Dexmedetomidine Induced Sleep
This study is ongoing, but not recruiting participants.
Sponsor:
Massachusetts General Hospital
Information provided by (Responsible Party):
Oluwaseun Johnson-Akeju, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01485380
First received: November 30, 2011
Last updated: April 25, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Dexmedetomidine Induced Sedation |
Drug: dexmedetomidine |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Combined Electroencephalogram, Magnetic Resonance Imaging-Positron Emission Tomography of Dexmedetomidine Induced Sleep |
Resource links provided by NLM:
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- Combined Magnetic Resonance-Positron Emission Tomography Imagery of the brain under light sedation. [ Time Frame: 1.5hrs ] [ Designated as safety issue: No ]This study is intended to elicit the regions of the brain that are involved in dexmedetomidine induced sedation. This will be done with a functional imaging scan of the brain after with the imagery data will be processed and analyzed to help understand the regions of the brain implicated.
| Estimated Enrollment: | 4 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Drug: dexmedetomidine
The dexmedetomidine infusion will be individualized to each study participant by a target plasma concentration where LOC is initially observed. LOC will be assayed by specific auditory and verbal stimuli.
Other Name: precedex
|
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status I
- 18 to 35 years of age
Exclusion Criteria:
- MRI and/or PET screening criteria not met
- Abnormal sleep habits/known or suspected sleep disorder(s)
- Taking medication that alters sleep, cognitive function, or both -History of a known neurological or psychiatric problem -Younger than 18 or older than 35 years of age
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01485380
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
| Principal Investigator: | Oluwaseun Johson-Akeju, M.D | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Oluwaseun Johnson-Akeju, Assistant in Anesthaesia, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01485380 History of Changes |
| Other Study ID Numbers: | 2011-P-002333 |
| Study First Received: | November 30, 2011 |
| Last Updated: | April 25, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
Dexmedetomidine Sleep MRI-PET EEG |
Additional relevant MeSH terms:
|
Dexmedetomidine Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013