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

Tracking Information

First Received Date ^ICMJE

February 16, 2012

Last Updated Date

March 2, 2012

Start Date ^ICMJE

August 2005

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01543633 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

EEG Studies of Induction and Recovery From Propofol Induced General Anesthesia

Official Title ^ICMJE

Electroencephalogram Studies of Induction and Recovery From Propofol Induced General Anesthesia

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).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science

Condition ^ICMJE

Brain Activity Under Sedation

Intervention ^ICMJE

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).

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 36 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01543633

Other Study ID Numbers ^ICMJE

2005P001549, 5DP1OD003646

Has Data Monitoring Committee

Yes

Responsible Party

Emery Brown, Massachusetts General Hospital

Study Sponsor ^ICMJE

Massachusetts General Hospital

Collaborators ^ICMJE

National Institutes of Health (NIH)

Investigators ^ICMJE

Principal Investigator:

Emery N Brown, M.D., Ph.D.

Massachusetts General Hospital

Information Provided By

Massachusetts General Hospital

Verification Date

March 2012

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

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