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
  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:
  • 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.


Enrollment: 20
Study Start Date: September 2012
Study Completion Date: July 2013
Primary Completion Date: July 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 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.
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: September 24, 2014
Last Updated: October 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Dexmedetomidine
Sleep
MRI-PET
EEG

Additional relevant MeSH terms:
Dexmedetomidine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Analgesics, Non-Narcotic
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014