EEG Studies of Induction and Recovery From Propofol Induced General Anesthesia

NCT ID: NCT01543633

Last Updated: 2022-01-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2020-07-31

Brief Summary

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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

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Conditions

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Brain Activity Under Sedation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

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).

Interventions

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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).

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

36 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Emery Brown

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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5DP1OD003646

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2005P001549

Identifier Type: -

Identifier Source: org_study_id

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