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EEG Studies of Induction and Recovery From Propofol Induced General Anesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01543633
Recruitment Status : Active, not recruiting
First Posted : March 5, 2012
Last Update Posted : December 2, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Brain Activity Under Sedation Drug: Propofol

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Electroencephalogram Studies of Induction and Recovery From Propofol Induced General Anesthesia
Study Start Date : August 2005
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
Drug Information available for: Propofol
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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).


Outcome Measures

Primary Outcome Measures :
  1. Localize and track brain activity under propofol sedation. [ Time Frame: 11 hours ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 36 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( U.S. NIH Grant/Contract )
First Posted: March 5, 2012    Key Record Dates
Last Update Posted: December 2, 2016
Last Verified: December 2016

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