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

NCT01485380 | Completed Results

• 1 other identifier: 2011-P-002333
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Dexmedetomidine Induced Sedation

Keywords

Dexmedetomidine; Sleep; MRI-PET; EEG

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Changes in the Brains Default Mode Network.

  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.

  1.5hrs

Study Arms (1)

Active study arm

EXPERIMENTAL

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

Interventions

dexmedetomidine DRUG

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.

Also known as: precedex

Active study arm

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I
• to 35 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Oluwaseun Johnson-Akeju
• Organization: Massachusetts General Hospital

oluwaseun.akeju@mgh.harvard.edu

6177247200

Study Officials

• Oluwaseun Johnson-Akeju, M.D

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant in Anesthaesia

Study Record Dates

• First Submitted: November 30, 2011
• First Posted: December 5, 2011
• Study Start: September 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: January 8, 2019
• Results First Posted: October 10, 2014

Record last verified: 2019-01

Locations

US (1)