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EEG Studies of Induction and Recovery From Propofol Induced General Anesthesia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
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
History of Changes
  Purpose

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).


Condition Intervention
Brain Activity Under Sedation
 Drug: Propofol

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Electroencephalogram Studies of Induction and Recovery From Propofol Induced General Anesthesia

Resource links provided by NLM:

Drug Information available for: Propofol
U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 80
Study Start Date: August 2005
Estimated Primary Completion Date: December 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 a base MRI scan of the brain. On a separate day propofol will be administered with concurrent EEG while subjects respond to stimuli.
 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).

  Eligibility

Ages Eligible for Study:   18 Years to 36 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01543633

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institutes of Health (NIH)
Investigators
Principal Investigator: Emery N Brown, M.D., Ph.D. Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Emery Brown, Emery N. Brown, M.D., Ph.D., Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01543633     History of Changes
Other Study ID Numbers: 2005P001549, 5DP1OD003646
Study First Received: February 16, 2012
Last Updated: March 2, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Anesthetics
Propofol
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on May 23, 2013