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: April 25, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

November 30, 2011

Last Updated Date

April 25, 2013

Start Date ^ICMJE

September 2012

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01485380 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label

Condition ^ICMJE

Dexmedetomidine Induced Sedation

Intervention ^ICMJE

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

Study Arm (s)

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.

Intervention: Drug: dexmedetomidine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01485380

Other Study ID Numbers ^ICMJE

2011-P-002333

Has Data Monitoring Committee

Yes

Responsible Party

Oluwaseun Johnson-Akeju, Massachusetts General Hospital

Study Sponsor ^ICMJE

Massachusetts General Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Oluwaseun Johson-Akeju, M.D

Massachusetts General Hospital

Information Provided By

Massachusetts General Hospital

Verification Date

April 2013

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

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