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An Electroencephalogram Study of Induction and Recovery from Propofol Anesthesia July 7, 2005

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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An Electroencephalogram Study of Induction and Recovery from Propofol Anesthesia July 7, 2005

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  1. 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

  2. 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

  3. Overview • Protocol History • Research Background • Walk Through Protocol • Human Research Protection/ Safety

  4. 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)

  5. 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

  6. Clinical Obs., EEG, BIS Induction of Anesthesia Site Specific Changes in Neural Activity EEG Source Localization  GABA-A,  NMDA (?) Research Background

  7. 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

  8. 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.

  9. 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)

  10. 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)

  11. 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

  12. Study Protocol: Overview DIAGRAM W/ CONCENTRATION PROFILE

  13. 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

  14. ACLS Cart, Defibrillator • PICTUR OF ACLS CART AND DEFIB

  15. Anesthesia Cart and Anesthesia Machine • PICTURE OF ANESTHESIA CART AND ANESTHESIA MACHINE

  16. O2 Supply: Wall + E-cylinders • PICTURE OF WALL AIR/02 AND E-CYLINDERS

  17. Monitors + iSTAT

  18. 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)

  19. Medical Staff Responsibilities • Clinical Anesthesiologist • care of study subject • PACU care • Study Anesthesiologist • organization and execution of study protocol • STANPUMP infusion

  20. 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

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