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Propofol in the GI Suite: Is it safe

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Title: Propofol in the GI Suite: Is it safe


1
Propofol in the GI Suite Is it safe?
Steven L. Shafer, M.D. Professor of Anesthesia,
Stanford University Adjunct Professor of
Pharmaceutical Sciences, UCSFEditor in Chief,
Anesthesia Analgesia
2
Disclosure
  • Sedation is a labeled indication for all of the
    approved drugs I will be discussing.
  • Ive consulted with Roche (midazolam),
    AstraZeneca (propofol), Theravance (THRX-918661),
    and Guilford Pharmaceuticals (Aquavan)
  • Im the Chair of the Anesthesia Advisory Panel
    for Ethicon Endo-Surgery, and have been involved
    with the development of their Sedation Delivery
    System for 5 years

3
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4
Is Propofol Safe in the GI Suite
  • I will assume that if propofol is safe if it is
    administered by an anesthesiologist.
  • If not, then you are at the wrong lecture
  • The question is whether propofol is safe in the
    GI suite if it is NOT administered by an
    anesthesiologist.
  • This implies propofol administration by a nurse.

5
Yikes!
  • This is very controversial because
  • It affects our income.
  • If nurses can give propofol safely in the GI
    suite, then why not in the OR?
  • It affects our pride.
  • Weve trained for years, yet weve still had
    nightmare cases of sedation where it took all our
    skill to manage the patient.
  • We fear for the wellbeing of the patient.
  • If the patient was your mom, would you want a
    nurse or an anesthesiologist to give the propofol.

6
Key Question
  • We will start by addressing the key question
    what is best for the patient?
  • After that, we will consider some of the
    political, economic, and regulatory baggage that
    accompanies the issue.

7
Colonoscopy Recommendations for Risk-Free
Individuals
  • Colonoscopy screening at ages 50, 60, 70, and 80
  • Based on 2005 census data, works out to 9.3
    million colonoscopies / year
  • Approximately 35,000 anesthesiologists in the
    United States
  • Schubert, Mayo Clin Proc. 200176995-1010
  • Thats at least 295 colonoscopies / year /
    anesthesiologist
  • In addition to the 714 surgical procedures / year
    / anesthesiologist

8
Observation 1
  • It is not in the patients interest that they
    receive anesthesiologist delivered propofol.
  • We simply cant provide the service
  • They will die of colon cancer waiting for their
    colonoscopy
  • Nonstarter

9
Is Current Practice Safe?
  • Current practice consists of a midazolam and an
    opioid, typically meperidine or fentanyl
  • Must first consider the clinical pharmacology of
    midazolam

10
Midazolam Risks
The Introduction of Versed
11
Midazolam and Diazepam Clinical Pharmacology
(as originally introduced into clinical practice)
Elimination
Equipotent
Onset
Half-Life
Duration
Doses
Diazepam
"slow"
40 hr
"long"
10 mg
Midazolam
"fast"
4 hr
"short"
5 mg
12
Result of initial dosing guidelines
  • 1600 adverse reactions and 86 deaths associated
    with midazolam in the first 5 years after its
    introduction in the United States.
  • Department of Health and Human Services, Office
    of Epidemiology and Biostatistics, Center for
    Drug Evaluation and Research, Data Retrieval Unit
    HFD-737, June 27, 1989
  • Nearly all were associated with midazolam for
    sedation during endoscopy

13
FDAS REGULATION OF THE NEW DRUG
VERSED
HEARINGS
BEFORE A
SUBCOMMITTEE OF THE
COMMITTEE ON
GOVERNMENT OPERATIONS
HOUSE OF REPRESENTATIVES
ONE HUNDREDTH CONGRESS
SECOND SESSION
MAY 5 AND 10, 1988
14
Midazolam Sedation for Endoscopy
Adapted from Bell, J Clin Pharmacol 1987
Feb23(2)241-3
15
Midazolam-Opioid Interactions(young volunteers)
Adapted from Kissen et al, Anesth Analg 7265-69,
1990
16
Benzodiazepine EEG Effects
Midazolam
V/sec)
Flumazenil
m
EEG Amplitude within 11.5-30 Hz (
Bretazenil
Ro 19-4603
m
Blood concentration (
g/ml)
17
EEG Effects of Midazolam
Adapted from Bührer, CPT 48555-567, 1990
18
Revised Midazolam Comparative Pharmacology
Plasma-Effect Site
Equilibration Half-Life
Potency
range (average)
range (mean)
1-2.4 min
406-1256 ng/ml
Diazepam
(1.6 min)
(958 ng/ml)
1.6-6.8 min
94-385 ng/ml
Midazolam
(4.8 min)
(190 ng/ml)
19
1991 Sedation Risks with Midazolam
  • Arrowsmith et al, FDA
  • 21,011 procedures
  • Complications with midazolam and diazepam
  • Serious cardiorespiratory complications
    54/10,000
  • Death 3/10,000

Results from the American Society for
Gastrointestinal Endoscopy/U.S. Food and Drug
Administration collaborative study on
complication rates and drug use during
gastrointestinal endoscopy. Gastrointestinal
Endoscopy, 1991
20
Current Sedation Risks with Midazolam
  • Vargo et al, Cleveland Clinic
  • 49 patients undergoing upper endoscopy
  • 57 of patients experienced 54 episodes of apnea
    as identified by capnometry
  • gt 30 seconds (mean 60 seconds)
  • 50 of episodes led to desaturation (SaO2lt90)
  • 100 missed by clinical observation
  • Over half of the patients were at risk

Gastrointestinal Endoscopy 55826-831, 2002
21
Observation 2
  • Midazolam is not intrinsically safe
  • Midazolam for sedation has caused a large number
    of deaths
  • Like propofol, midazolam shows profound synergy
    with opioids at inducing ventilatory depression

22
Is Propofol Safe?
  • What are the relevant PK characteristics of
    propofol?

23
Propofol Pharmacokinetics
Schnider et al, Anesthesiology 1998881170-82
24
Diprifusor Target Controlled Drug Delivery
25
Extended PK/PD Concept The Effect Site
26
Fentanyl TCI
27
Fentanyl TCIPlasma Target
28
Fentanyl TCIEffect Site Target
29
Propofol Plasma Control
30
Propofol Effect Site Control
6
Induction
Incision
4
Prep
Titrating
Propofol (mcg/ml)
Skin Closure
2
Waiting for
Surgeon
Maintenance
Awaken
0
0
10
20
30
40
50
60
Minutes
31
50 Effect Site Decrement Time
32
Is Propofol Safe?
  • What studies have examined propofol safety?

33
Propofol is Coming to a GI Suite Near You
www.drnaps.org
34
Dr. NAPS
  • Painless exams with total amnesia
  • Rapid endo and prep room turnover
  • Rapid discharge, usually within 15-20 minutes
  • Rapid return of patients to work or leisure
  • Improved provider efficiency
  • Protocol believed to be safer than traditional
    sedation
  • Improved ambiance and relaxation of techs and
    nurses

www.drnaps.org
35
Dr. NAPS
  • Better patient comprehension and compliance with
    discharge instructions
  • Patients delighted with you and your endo unit
  • Colonoscopy as a screening procedure gains
    popularity
  • Good to excellent patient memory of your findings
    and recommendations
  • Practice expansion through patient delight in
    lack of procedural discomfort

www.drnaps.org
36
Dr. NAPS
  • Claims gt 27,000 patients without an adverse event.

www.drnaps.org
37
Dr. NAPS Safety Net
  • Rescue Drugs
  • Atropine
  • Ephedrine
  • Oxygen
  • Standard monitoring
  • Capnography
  • Nurse ventilation confirmation
  • Nurse - patient interface
  • Airway rescue
  • Nurse
  • gastroenterologist
  • respiratory technician
  • emergency room physician
  • Anesthesiologist

www.drnaps.org
38
Propofol Sedation during Endoscopic
ProceduresSafe and Effective Administration by
RegisteredNurses Supervised by Endoscopists
  • Tohda et al
  • Endoscopy. 200638360-7 (April)
  • Private hospital in Japan
  • Propofol protocol developed by anesthesiologists
    prior to study
  • 27,500 endoscopy patients

39
Propofol Sedation during Endoscopic
ProceduresSafe and Effective Administration by
RegisteredNurses Supervised by Endoscopists
40
Propofol Sedation during Endoscopic
ProceduresSafe and Effective Administration by
RegisteredNurses Supervised by Endoscopists
41
Sedation with Propofol for Routine ERCP in
High-RiskOctogenarians A Randomized, Controlled
Study
  • Riphaus et al
  • Am J Gastroenterol. 2005 Sep1001957-63
  • 150 consecutive patients 80 years old
  • 91 ASA III
  • Propofol alone vs. Midazolam/meperidine

42
Sedation with Propofol for Routine ERCP in
High-RiskOctogenarians A Randomized, Controlled
Study
43
Nurse-Administered Propofol Versus Midazolamand
Meperidine for Upper Endoscopy in Cirrhotic
Patients
  • Weston et al.
  • Am J Gastroenterol. 2003,Nov982440-7
  • 20 outpatients with known chronic liver disease
  • Patients undergoing variceal screening

44
Nurse-Administered Propofol Versus Midazolamand
Meperidine for Upper Endoscopy in Cirrhotic
Patients
45
Observation 3
  • Propofol has now been studied numerous times for
    GI sedation, given by a nurse
  • The available data suggest it is safe when used
    for moderate sedation
  • I have not cherry picked the articles to make a
    point there are no published studies that Im
    aware of showing a significant risk of propofol
    sedation in the hands of a properly trained nurse

46
Lets get political!
  • What do societies say?
  • Whose interests do they represent?

47
Blue Cross Policy
  • September 22, 2005
  • "The routine assistance of an Anesthesiologist or
    CRNA for average risk patients undergoing
    standard upper and/or lower gastrointestinal
    endoscopic procedures is considered not medically
    necessary."
  • It is considered medically necessary in some
    settings.

48
anesthesia services including monitored
anesthesia care (MAC) is considered medically
necessary during gastrointestinal endoscopic
procedures in any of the following situations"
  • prolonged or therapeutic procedure requiring deep
    sedation or
  • history of or anticipated intolerance to standard
    sedatives or
  • increased risk for complication due to severe
    comorbidity (American Society of
    Anesthesiologists (ASA)) class III physical
    status or greater or
  • patient of extreme age lt1 or gt70 or
  • pregnancy or
  • history of drug or alcohol abuse or
  • uncooperative or acutely agitated patients (e.g.,
    delirium, organic brain disease, senile
    dementia) or

49
anesthesia services including monitored
anesthesia care (MAC) is considered medically
necessary during gastrointestinal endoscopic
procedures in any of the following situations"
  • increased risk for airway obstruction due to
    anatomic variant including any of the following
  • history of previous problems with anesthesia or
    sedation or
  • history of stridor or sleep apnea or
  • dyamorphic facial features such as Pierre-Robin
    syndrome or trisomy-21 or
  • presence of oral abnormalities including but not
    limited to a small oral opening (less than 3cm in
    an adult), high arched palate, macroglossia,
    tonsillar hypertrophy, or a non-visible uvula or
  • neck abnormalities including but not limited to
    short neck, obesity involving the neck and facial
    structures, limited neck extension, decreased
    hyoid-mental distance (less than 3cm in an
    adult), neck mass, cervical spine disease or
    trauma, tracheal deviation, or advanced
    rheumatoid arthritis or
  • jaw abnormalities including but not limited to
    micrognathia, retrognathia, trismus, or
    significant malocclusion.

50
2004 Joint Recommendation
  • Issued by
  • The American College of Gastroenterology
  • American Gastroenterological Association
  • American Society for Gastrointestinal Endoscopy

51
RECOMMENDATIONS ON THE ADMINISTRATION OF SEDATION
FOR THE PERFORMANCE OF ENDOSCOPIC PROCEDURES
  • In general, diagnostic and uncomplicated
    therapeutic endoscopy and colonoscopy are
    successfully performed with moderate (conscious)
    sedation.
  • Compared to standard doses of benzodiazepines and
    narcotics, propofol may provide faster onset and
    deeper sedation.

52
RECOMMENDATIONS ON THE ADMINISTRATION OF SEDATION
FOR THE PERFORMANCE OF ENDOSCOPIC PROCEDURES
  • More rapid cognitive and functional recovery can
    be expected with the use of propofol as a single
    agent.
  • Clinically important benefits over standard
    sedatives have not been consistently demonstrated
    in average-risk patients undergoing standard
    routine upper and lower endoscopy. Further
    randomized clinical trials are needed in this
    setting.

53
RECOMMENDATIONS ON THE ADMINISTRATION OF SEDATION
FOR THE PERFORMANCE OF ENDOSCOPIC PROCEDURES
  • Propofol may have more clinically significant
    advantages when used for prolonged and
    therapeutic procedures, including, but not
    limited to, ERCP and EUS.
  • There are data to support the use of propofol by
    adequately trained non-anesthesiologists. Large
    case series indicate that with adequate training
    physician-supervised nurse administration of
    propofol can be done safely and effectively. The
    regulations governing the administration of
    propofol by nursing personnel vary from state to
    state.

54
RECOMMENDATIONS ON THE ADMINISTRATION OF SEDATION
FOR THE PERFORMANCE OF ENDOSCOPIC PROCEDURES
  • Patients receiving propofol should receive care
    consistent with deep sedation. Personnel should
    be capable of rescuing the patient from general
    anesthesia and/or severe respiratory depression.
  • A designated individual, other than the
    endoscopist, should be present to monitor the
    patient throughout the procedure and should be
    able to recognize and assist in the management of
    complications.

55
RECOMMENDATIONS ON THE ADMINISTRATION OF SEDATION
FOR THE PERFORMANCE OF ENDOSCOPIC PROCEDURES
  • The routine assistance of an anesthesiologist/anes
    thetist for average risk patients undergoing
    standard upper and lower endoscopic procedures is
    not warranted.
  • Physician-nurse teams administering propofol
    should possess the training and skills necessary
    to rescue patients from severe respiratory
    depression.

56
RECOMMENDATIONS ON THE ADMINISTRATION OF SEDATION
FOR THE PERFORMANCE OF ENDOSCOPIC PROCEDURES
  • Complex procedures and procedures in high-risk
    patients may justify the use of an
    anesthesiologist/anesthetist to provide conscious
    and/or deep sedation. In such cases this provider
    may bill separately for their professional
    services.
  • The use of agents to achieve sedation for
    endoscopy must conform to the policies of the
    individual institution.

57
RECOMMENDATIONS ON THE ADMINISTRATION OF SEDATION
FOR THE PERFORMANCE OF ENDOSCOPIC PROCEDURES
  • Reimbursement for conscious sedation is included
    within the codes covering endoscopic procedures.
  • Billing separately for conscious sedation has
    been targeted by the OIG as a possible fraud and
    abuse violation, and is not recommended.

58
Propofol and Endoscopy
Peer Reviewed Manuscripts in Medline
59
Continuum of Depth of SedationDefinition of
General Anesthesia and Levels of Sedation /
Analgesia(Developed by the American Society of
Anesthesiologists)(Approved by ASA House of
Delegates on October 13, 1999)
Reflex withdrawal from a painful stimulus is
NOT considered a purposeful response
60
Practice Guidelines for Sedation and Analgesia by
Non-Anesthesiologists
  • Approved by ASA, October 17, 2001
  • Endorsed by ASGE, AAOMS, AAR, Adopted by JCAHO
  • Monitoring
  • level of consciousness, ventilation, oxygenation,
    hemodynamics
  • Training
  • pharmacology, airway, recognize and manage
    complications, ACLS
  • Drugs
  • opioids, benzodiazepines, propofol, methohexital,
    ketamine
  • Miscellaneous
  • supplemental oxygen, emergency equipment

61
What do Anesthesiologists Say?
  • Only anesthesiologists can use propofol because
    thats what it says on the package insert.
  • Hard to defend based on available evidence.
  • Unclear if anesthesiologists are looking out for
    their patients or their turf.
  • Major push by GI doctors to change that, given
    the lack of a safety signal when propofol is used
    by nurses under careful guidelines.
  • They wont be able to change the label, because
    only the company that owns the label has the
    authority to change it.

62
Technologies to Make Propofol Sedation Safer
  • Are they needed, or is propofol safe enough
    already?
  • Aquavan
  • Propofol prodrug
  • Ethicon Sedation Delivery System
  • Integrated propofol monitoring and delivery
  • I have significant COI, so interpret my comments
    skeptically

63
Aquavan
  • Developed as a non-stinging propofol prodrug.
  • Causes transient (lt 1 min) burning in the
    genitals and anus.

64
AquavanWater soluble propofol prodrug
Fechner et al, Anesthesiology 2003 99303
65
Aquavan
Fechner et al, Anesthesiology 2003 99303
66
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67
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68
Propofol Sedation Delivery System
69
The Automated Responsiveness Measure for
Procedural Sedation
  • Invented by Randy Hickle, MD
  • Potential as a feedback system for sedation
    delivery

70
Continuum of Depth of SedationDefinition of
General Anesthesia and Levels of Sedation /
Analgesia(Developed by the American Society of
Anesthesiologists)(Approved by ASA House of
Delegates on October 13, 1999)
Reflex withdrawal from a painful stimulus is
NOT considered a purposeful response
71
First Loss of ARMvs. Transition to Deep Sedation
5
Loss of ARM
4.5
Transition to Deep Sedation
g/ml)
4
3.5
3
2.5
Propofol Effect Site (
2
1.5
1
0.5
0
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
Subject
72
ARM Summary
  • First loss of ARM consistently precedes deep
    sedation
  • Alerts clinician to sedation level
  • Automatically reduces dose if patient remains
    non-responsive
  • Override required for increasing dose
  • ARM provides basis to individualize dosing
  • Assessment of drug effect for non-anesthesiologist
  • Reduces risk of transition to general anesthesia

Doufas et al. Anesthesiology. 2004 1011112-21.
73
Sedation is about relieving stress
74
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