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Combined Electroencephalogram, Magnetic Resonance Imaging-Positron Emission Tomography of Dexmedetomidine Induced Sleep

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oluwaseun Johnson-Akeju, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01485380
First received: November 30, 2011
Last updated: October 8, 2014
Last verified: October 2014

November 30, 2011
October 8, 2014
September 2012
July 2013   (final data collection date for primary outcome measure)
Number of Participants With Changes in the Brains Default Mode Network. [ Time Frame: 1.5hrs ] [ Designated as safety issue: No ]
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.
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.
Complete list of historical versions of study NCT01485380 on ClinicalTrials.gov Archive Site
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Combined Electroencephalogram, Magnetic Resonance Imaging-Positron Emission Tomography of Dexmedetomidine Induced Sleep
Combined Electroencephalogram, Magnetic Resonance Imaging-Positron Emission Tomography of Dexmedetomidine Induced Sleep

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Dexmedetomidine Induced Sedation
Drug: 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.
Other Name: precedex
Experimental: Active study arm
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.
Intervention: Drug: dexmedetomidine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01485380
2011-P-002333
No
Oluwaseun Johnson-Akeju, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Oluwaseun Johson-Akeju, M.D Massachusetts General Hospital
Massachusetts General Hospital
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP