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MGH DACC Clinical Practices Committee. An Electroencephalogram Study of Induction and Recovery from Propofol Anesthesia July 7, 2005 PI: Brown CoPI: Walsh, Purdon, Mullaly, Kwo, Harrell, Williams, Dray, Bonmassar, Angelone, Hamalainen, Barlow, Matten. Issues for DACC.

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MGH DACC Clinical Practices Committee

An Electroencephalogram Study of Induction and Recovery from Propofol Anesthesia

July 7, 2005

PI: Brown

CoPI: Walsh, Purdon, Mullaly, Kwo, Harrell, Williams, Dray, Bonmassar, Angelone, Hamalainen, Barlow, Matten


Issues for dacc
Issues for DACC

  • Permission to conduct EEG/propofol study

    • Identical to DACC-approved EEG/fMRI/propofol study, but with EEG only, no fMRI

  • Permission to implement protocol at the GCRC Bioimaging Core facility (CNY 149) as an offsite location


Overview
Overview

  • Protocol History

  • Research Background

  • Walk Through Protocol

  • Human Research Protection/ Safety


Protocol history
Protocol History

  • Similar to BIS/propofol protocol by Rosow/Kearse (1998)

  • Similar to EEG/fMRI/Anesthesia by Brown

    • IRB approved (1999-P-010748 MGH)

    • Reviewed by MGH DACC CPC

    • MGH Mallinckrodt GCRC (GAC)


Eeg propofol vs eeg fmri propofol
EEG/propofol vs. EEG/fMRI/propofol

  • EEG only, no fMRI under anesthesia

    • Study conducted in standard clinical area

  • Airway management with bag-mask

  • ASA I Study Subjects ages 18-36

  • Conducted in GCRC Bioimaging core

    • Meets requirements for off-site anesthesia

  • EEG source localization

    • Requires structural MRI in separate session


Research background

Clinical Obs., EEG, BIS

Induction of Anesthesia

Site Specific Changes in Neural Activity

EEG Source Localization

 GABA-A,  NMDA (?)

Research Background


Eeg source localization

Somatosensory-Motor Exp’t: Early somatosensory peak, followed by motor response

EEG Source Localization

  • Combine structural/conductivity information from anatomic MRI to “localize” auditory, somatosensory, and cognitive function

  • Faster time scale than fMRI, but spatial resolution lower w/ limited subcortical visibility


Our objective
Our Objective followed by motor response

To correlate simultaneous measurements of

  • electroencephalogram (EEG)

  • plasma levels of propofol

  • well-defined behavioral markers

  • changes in source localization

    during induction of and recovery from

    general anesthesia.


Walk through protocol
Walk Through Protocol followed by motor response

  • Study subject pre-anesthesia clinical assessment

    • Prior to study

    • GCRC White 13

  • Induction and Recovery from Propofol

  • Study subject follow-up

  • Separate anatomic MRI scan (30 minutes)


Study protocol clinical assessment
Study Protocol: Clinical Assessment followed by motor response

  • Subject Recruitment

    • Healthy male and female volunteers

    • Ages 18-36

    • Total 44 subjects recruited

  • ASA physical status I

  • Telephone Questionnaire

  • Pre-study Assessment (2 hours)

    • History and Physical Examination

    • Toxic Screen and Pregnancy Test (female subjects)


Study protocol clinical preparation
Study Protocol: Clinical Preparation followed by motor response

  • Toxic screen and pregnancy test

  • Standard Anesthesia Monitors:

    • ECG, BP cuff, pulse oximeter, capnogram

  • Additional Monitors:

    • EEG, arterial line

  • Airway Maintenance:

    • Bag mask

  • Phenylephrine to maintain BP

  • Additional Drugs:

    • bicitra, ondansetron


Study protocol overview
Study Protocol: Overview followed by motor response

DIAGRAM W/ CONCENTRATION PROFILE


Equipment supplies at cny 149
Equipment/ Supplies at CNY 149 followed by motor response

  • ACLS cart

  • Defibrillator

  • Anesthesia Cart

  • Airway equipment

  • Anesthesia Machine

  • O2 and Air (Wall and E-cylinders)

  • Monitors (FiO2, SaO2, EtCo2, ECG, NIBP, P1)

  • Laboratory Testing (urine pregnancy, tox screen, ABG)

  • iSTAT

  • EEG machine and electrodes

  • Routinely maintained by Biomedical Engineering


Acls cart defibrillator
ACLS Cart, Defibrillator followed by motor response

  • PICTUR OF ACLS CART AND DEFIB


Anesthesia cart and anesthesia machine
Anesthesia Cart and Anesthesia Machine followed by motor response

  • PICTURE OF ANESTHESIA CART AND ANESTHESIA MACHINE


O2 supply wall e cylinders
O2 Supply: Wall + E-cylinders followed by motor response

  • PICTURE OF WALL AIR/02 AND E-CYLINDERS


Monitors istat
Monitors + iSTAT followed by motor response


Nursing responsibilities
Nursing Responsibilities followed by motor response

  • Page study Physician

  • Urine toxicity screen

  • Urine pregnancy test

  • ART line setup available

  • ABG sampling + analysis w/ iSTAT

  • Preparation of blood samples for storage (propofol)


Medical staff responsibilities
Medical Staff Responsibilities followed by motor response

  • Clinical Anesthesiologist

    • care of study subject

    • PACU care

  • Study Anesthesiologist

    • organization and execution of study protocol

    • STANPUMP infusion


Preliminary studies

MLAEP, 4.0 ug/ml followed by motor response

MLAEP, 0.0 ug/ml

MLAEP, 2.0 ug/ml

1

1

1

0.5

0.5

0.5

P

P

a

a

0

0

0

N

b

P

N

Amplitude (uV)

a

b

-0.5

-0.5

-0.5

N

N

b

a

N

-1

N

-1

-1

a

a

-1.5

-1.5

-1.5

0

20

40

60

80

100

0

20

40

60

80

100

0

20

40

60

80

100

Post-stimulus latency (msec)

Post-stimulus latency (msec)

Post-stimulus latency (msec)

Power Spectrum, 0.0 ug/ml

Power Spectrum, 2.0 ug/ml

Power Spectrum, 4.0 ug/ml

6000

6000

6000

5000

5000

5000

/Hz)

4000

4000

4000

2

3000

3000

3000

Power (uV

2000

2000

2000

1000

1000

1000

0

0

0

0

10

20

30

40

0

10

20

30

40

0

10

20

30

40

Frequency (Hz)

Frequency (Hz)

Frequency (Hz)

EEG, 2.0 ug/ml

EEG, 0.0 ug/ml

EEG, 4.0 ug/ml

40

40

40

20

20

20

0

0

0

Amplitude (uV)

-20

-20

-20

-40

-40

-40

0

1

2

3

4

0

1

2

3

4

0

1

2

3

4

Time (sec)

Time (sec)

Time (sec)

Preliminary Studies

MLAEP

EEG

Power

Spectrum

EEG time series

Propofol:

0.0 ug/ml

2.0 ug/ml

4.0 ug/ml


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