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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

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
  • 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
  • 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
  • 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

DIAGRAM W/ CONCENTRATION PROFILE

equipment supplies at cny 149
Equipment/ Supplies at CNY 149
  • 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
  • PICTUR OF ACLS CART AND DEFIB
anesthesia cart and anesthesia machine
Anesthesia Cart and Anesthesia Machine
  • PICTURE OF ANESTHESIA CART AND ANESTHESIA MACHINE
o2 supply wall e cylinders
O2 Supply: Wall + E-cylinders
  • PICTURE OF WALL AIR/02 AND E-CYLINDERS
nursing responsibilities
Nursing Responsibilities
  • 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
  • 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

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