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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Oluwaseun Johnson-Akeju, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01485380
First received: November 30, 2011
Last updated: August 14, 2013
Last verified: August 2013
  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: 30
Study Start Date: September 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (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: August 14, 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 April 23, 2014