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
Results First Received: September 24, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Dexmedetomidine Induced Sedation
Intervention: Drug: dexmedetomidine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Active Study Arm  
STARTED     20  
COMPLETED     17  
NOT COMPLETED     3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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.


Baseline Measures
    Active Study Arm  
Number of Participants  
[units: participants]
  20  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     20  
>=65 years     0  
Gender  
[units: participants]
 
Female     11  
Male     9  



  Outcome Measures

1.  Primary:   Number of Participants With Changes in the Brains Default Mode Network.   [ Time Frame: 1.5hrs ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Oluwaseun Johnson-Akeju
Organization: Massachusetts General Hospital
phone: 6177247200
e-mail: oluwaseun.akeju@mgh.harvard.edu


No publications provided


Responsible Party: Oluwaseun Johnson-Akeju, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01485380     History of Changes
Other Study ID Numbers: 2011-P-002333
Study First Received: November 30, 2011
Results First Received: September 24, 2014
Last Updated: October 8, 2014
Health Authority: United States: Institutional Review Board