EEG Studies of Induction and Recovery From Propofol Induced General Anesthesia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Massachusetts General Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Emery Brown, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01543633
First received: February 16, 2012
Last updated: March 2, 2012
Last verified: March 2012

February 16, 2012
March 2, 2012
August 2005
December 2013   (final data collection date for primary outcome measure)
Localize and track brain activity under propofol sedation. [ Time Frame: 11 hours ] [ Designated as safety issue: No ]
The primary goal of this trial is to localize and track changes in brain activity during loss and recovery of consciousness induced by propofol using source localization from EEG recordings analyzed with spectral methods, source localizations techniques and event-related potentials.
Same as current
Complete list of historical versions of study NCT01543633 on ClinicalTrials.gov Archive Site
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EEG Studies of Induction and Recovery From Propofol Induced General Anesthesia
Electroencephalogram Studies of Induction and Recovery From Propofol Induced General Anesthesia

The purpose of this study is to investigate how the commonly used anesthetic drug propofol works in the brain to produce loss of consciousness. While under general anesthesia your brain waves will be measured using electroencephalogram (EEG). On a separate day, the patient's brain will be imaged using magnetic resonance imaging (MRI).

Not Provided
Interventional
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Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Brain Activity Under Sedation
Drug: Propofol
Propofol will be infused using a computer controlled delivery system running the program STANPUMP. Loss of consciousness will be defined as loss of response to auditory stimulus (button press).
Experimental: Active Study Arm
Subjects recruited into this study will be required to undergo a base MRI scan of the brain. On a separate day propofol will be administered with concurrent EEG while subjects respond to stimuli.
Intervention: Drug: Propofol
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
Not Provided
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy, non-smoking male and female volunteers, ages 18-36 with normal body weight.
  • American Society of Anesthesiologists (ASA) physical status I

Exclusion Criteria:

  • History of head trauma
  • Surgical aneurysm clips
  • Cardiac pacemaker
  • Prosthetic heart valve
  • Neurostimulator
  • Implanted pumps
  • Cochlear implants
  • Metal rods, plates
  • Screws
  • Intrauterine device
  • Hearing aid
  • Dentures (which might create NMR artifacts)
  • Metal injury to eyes
Both
18 Years to 36 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01543633
2005P001549, 5DP1OD003646
Yes
Emery Brown, Massachusetts General Hospital
Massachusetts General Hospital
National Institutes of Health (NIH)
Principal Investigator: Emery N Brown, M.D., Ph.D. Massachusetts General Hospital
Massachusetts General Hospital
March 2012

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