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

Not Applicable

Completed

• Conditions: Dexmedetomidine Induced Sedation
• Interventions: Drug: dexmedetomidine

• Registration Number: NCT01485380
• Lead Sponsor: Massachusetts General Hospital

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 available

Study Timeline

• Study First Submitted: 2011-11-30
• Study First Submitted QC: 2011-12-02
• Study First Posted: 2011-12-05
• Study Start: 2012-09
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Results First Submitted: 2014-09-24
• Results First Submitted QC: 2014-10-08
• Results First Posted: 2014-10-10
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-04
• Last Update Posted: 2019-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active study arm	dexmedetomidine	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Changes in the Brains Default Mode Network.	1.5hrs	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States