Off-site Anesthesia:
New Challenges
Pattricia S Klarr, M.D.
University of Michigan
What is the largest thing an
endoscopist can remove from an
anesthetized patient?
…A Surgeon!
Goals and Objectives
-compare providing anesthesia in the
endoscopy suite vs the operating room
-review procedure types and anesthetic
considerations
-discuss evolution of anesthetic
presence and effect of cost and
efficiency
-discuss impact of technology on the
future
Introduction
NORA:
Non
Operating
Room
Anesthesia
Also known as “Remote, offsite”
Challenges
1. Not working with
surgeons and
operating room
personnel
2. Lack of
understanding of
respective processes
3. Team building
4. Equipment
needs/space
requirements
If the relationship
of surgeons with
anesthesia is a
marriage without
love…
Then working with
gastroenterologists
is kind of like
this……
….but it doesn’t have to be.
How did we get here?
Vast majority of endoscopic procedures
can be done with (nurse) sedation
What has evolved is improvement of
technology and acuity of patients
NORA Rotation
“…doing 5 straight
days of the MPU is
a bit much. It’s not
that the hours are
bad, it’s just that
the pace and
workflow down here
can be pretty
frustrating, and
after a couple of
days of it, I feel like
I need to go back to
an OR or I may lose
my mind.”
NORA GI anesthesia is like
regular anesthesia because:
• Standardized monitoring
• Preprocedure evaluation and
preparation
It’s different because…
• Access to specialized equipment is
limited
• Less support from nearby anesthetic
colleagues
Other challenges
-inefficient scheduling
-lack of access to medical records-open
access patients
-equipment upkeep/stocking of supplies
-poor physical lay out
-tech and nursing unfamiliar with
anesthesia procedures
-unfamiliarity with
procedures/proceduralists
Conditions where anesthesia
support is indicated
Uncooperative/combative patient
Severe GERD
ASA>3
OSA, morbid obesity
Known/suspected difficult intubation
Known difficult to sedate
Chronic pain patients
Anesthesia support for:
Prolonged, difficult or painful procedures
Abnormal body habitus making
positioning difficult
Extremes of ages
Common Endoscopic
Procedures
-Colonoscopy
-Esophagogastroduodenoscopy (EGD)
-Endoscopic Ultrasonography (EUS)
-Endoscopic Retrograde
Cholangiopancreatography (ERCP)
-Double balloon enteroscopy (DBE)
-Endoscopic Mucosal Resection (EMR)
1. Mostly done with
light to moderate
sedation
2. Deep sedation
indicated with
1. Uncooperative
patient
2. Tolerant to
pain/antianxiety
medication
3. ASA>3
3. Anesthetic
choices include
midazolam/fentanyl
and or propofol
EGD
1. Moderate to
deep sedation
2. Consider
intubation with
severe reflux,
aspiration risk
EUS
1. Ultrasound
probe larger
2. May require
deep sedation
to general
anesthesia
-better yield
with FNA with
deeper
anesthetic
ERCP
1. Weigh risk
versus benefits of
deep sedation and
intubating patient.
2. Patients are
prone
3. GERD is
common
comorbidity
Double
Balloon
Endoscopy
1. General
anesthesia for
oral entry
2. Improves
visualization
of entire GI
tract.
Endoscopic
Mucosal
Resection
Removes mucosal lesions
while preserving the
submucosa and deeper
layers.
-diagnosis and treatment of
superficial lesions,
precancerous such as
Barrett's
-can be curative early
superficial cancers of GI tract
Deep vs. General Anesthesia
Risks Associated with GI
Endoscopy
-Hemodynamic instability
-elderly with limited cardiac reserve
-dehydrated after prep
-vagal response to GI distention
-Aspiration risk
-Airway access
-shared airway
Closed Claims NORA Findings
24 NORA Claims from 1990-2001
-half were from GI Suite
-most were MAC
-7of the 9 respiratory NORA events
were GI
4 of the 7 were during ERCP
Respiratory Events
-half respiratory events deemed
preventable with better monitoring
-respiratory complications associated
with
-nonvigilance
-inappropriate anesthetic choice
-untrained staff
-poor documentation
Further Findings
Inadequate oxygenation/ventilation was
most common damaging event
-oversedation
-lack of monitoring specifically 02 sat
monitor and capnography
-Reviewers judged care as substandard
in 54% of cases and preventable with
better monitoring in 32% of cases
Lessons
Learned/Recommendations
Standard monitors for all anesthesia
locations
Capnography and pulse oximitry can
prevent respiratory complications
Supplemental oxygen may disguise
hypoventilation if capnogram not used.
Safety Rules in Anesthesia!
-Reliable
-standardization of care
-minimum monitoring standards
capnography/pulse oximitry
Reliability
-continuous learning
-just and fair culture
individuals are appreciated and
accountable
-enthusiasm for teamwork
-debriefing
-support of leadership
-effective flow of information
Have anesthesia machine…
Will Travel
OK, we’re needed. We are safe and reliable.
They are going to love us in the endoscopy
suite now, right?
Propofol
Increase in colonoscopy for cancer
screening
Propofol sedation in many ways superior
to fentanyl / midazolam
rapid turn over = more volume
Very safe for use in moderate sedation
Pesky FDA Warning Label
“For general anesthesia or MAC
sedation, (propofol) should be
administered only by persons trained in
the administration of general
anesthesia and not involved in the
conduct of the surgical/diagnostic
procedure. “
“Much of this debate, during a time of
increasing health care costs and
decreasing physician reimbursements,
seems to reflect economic rather than
clinical concerns”
Douglas K Rex in The science and
politics of propofol, Am J.
Gastroenterology 2004
GASTROENTEROLOGY VIEW
“(T)his is purely a move by
gastroenterologists related to
reimbursement. It’s not for
improved patient safety; it’s not
for improved patient outcomes”.
Gervirtz, MD, MPH,
Gastroendonews, May 2005
ANESTHESIA RESPONSE
Revenue from Endoscopy
Gastroenterologist
Douglas Rex, M.D
“Trained Registered Nurses/endoscopy
teams can administer propofol safely
for endoscopy”
Gastroenterology 2005
Oral Surgeon Weighs In
-passing an ACLS course every 2 years
doesn’t make you skilled to handle
BMV an unconscious patient in
laryngospasm
-Joel Weaver, DDS, PhD
Anesthesia Progress, Summer 2006
Endoscopist-directed
Administration of Propofol:
A Worldwide Safety
Experience
Douglas K Rex, et al*
Findings:
In almost 650,000 cases of endoscopist
directed propofol sedation cases worldwide, there were only 15 major
complications:
11 need for intubation
4 deaths
0 permanent neurological injuries
Conclusion
Paraphrasing:
1. Endoscopist directed propofol
administration is safe.
2. Anesthesia providers have higher
costs relative to potential benefits
Oh, by the way…
-one of the limitations of the paper was
“the reliability of the data depended on
the self-reporting by the individual
participating centers…”
-and about the co-author, John A. Walker,
his conflict disclosure includes this:
CEO of Dr. NAPS
From the Internet
Dr. NAPS Inc. is a company that educates
and trains RNs and physicians in the
safe use of Propofol for procedural
sedation. We will assist you in
integrating the use of NAPS (nurse
administered Propofol sedation) into
your practice setting efficiently and
effectively. John Walker, CEO*
Gastroenterology Wants In
Position statement: nonanesthesiologist
administratration of propofol for GI
endoscopy: “…with adequate training,
physician-supervised nurse
administration of propofol can be done
safely and effectively” joint statement
of AASLD, ACG, AGA, and ASGE 2009
The fight over
propofol:
Michael Jackson death
June 2009
CMS guidelines
2010..propofol is only
indicated for general
anesthesia, MAC and for
the sedations of the
mechanically-ventilated
patients.
-Anesthesia Department
is responsible for
oversite
FDA deny ACG request 8/10
-arguments not compelling
-supports CMS requirement for
anesthesia training if use propofol
FDA-restriction
Off label use of propfol opened up
liability issues for gastroenterologists
bye-bye Dr NAPS
European instruction still available
Dr. Cohen responds:
“I believe the vast
majority of
endoscopists target
moderate sedation,
not deep. Therefore,
FDA’s concerns
about the risk of deep
sedation and general
anesthesia are
unwarranted.”
Cote study
Predictors of complications during
endoscopy:
-male gender
-high BMI
-ASA score of 3 or higher
-overall, deep sedation with propofol is
safe for advanced endoscopic cases
Cote
The vast majority of MAC cases (87.3%)
could be considered slipping into a
state of general anesthesia.
Metzner and Domino 2010
Many studies aren’t blinded are biased
and have conflict of interest
-reliable studies are hampered by low
incidence of severe adverse events, are
expensive and difficult to perform
NORA Near Miss Causes
Anesthesiology News, March, 2013
Ootaki Paper 2012
-retrospective analysis of 371 patients
-compared yield of EUS-FNA of solid
pancreatic masses
73% vs. 83% diagnostic with GA
-believe better patient cooperation
attributed to improvement
-cost impact?
Ootaki, et al, Anesthesiology 2012:
117:1044-50
Technology to
the Rescue?
From GI private practitioners
“FDA approval of (Sedasys) does not
make patient care “dummy-proof” or
safest for a given patient, because in
the event of a misadventure, a “rescue
expert’ is not immediately available to
assist. It is ludicrous to assume that
(training or new technology) will render
community gastroenterologist as
competent as anesthesia
professionals”
From the Oct. 9, 2013
Wall Street Journal: “Robots vs. Anesthesiologists”
J&J's New Sedation Machine Promises Cheaper Colonoscopies; Doctors Fight Back
By Jonathan D. Rockoff
Anesthesiologists, who are among the highest-paid physicians, have long fought
people in health care who target their specialty to curb costs. Now the doctors
are confronting a different kind of foe: machines.
A new system called Sedasys, made by Johnson & Johnson, would automate the
sedation of many patients undergoing colon-cancer screenings
….. Sedation Machine Promises Cheaper Colonoscopies
…… would automate (the) sedation …That could take anesthesiologists out of the
room, eliminating a big source of income for the doctors. More than $1 billion is
spent each year sedating...
Sedasys and ASA
Slide presentation and Panel discussion
At 2013 Annual Meeting in San Francisco
Log into ASA member website for
access-video “Is Sedasys a Disruptive
Device”
Ad hoc committee finalized
recommendations for Sedasys on
1/22/14
If all else
fails…
Video produced by Dr. Douglas Rex
What We Know
-endoscopy is a very low risk
-Propopfol has high patient satisfaction
-general anesthesia can improve
diagnostic outcomes
-the literature is full of biased studies
What We Don’t know
-Safety outcomes NAPs vs Anesthesia
-Replacing providers with machines is
cost-effective
But as long as these stories exist:
Propofol kills
Michael Jackson
3 year old dies in
dental office
Our jobs are safe!
Summary
-compared providing anesthesia in the
endoscopy suite vs the operating room
-reviewed procedure types and
anesthetic considerations
-discussed evolution of anesthetic
presence and effect of cost and
efficiency
-discussed impact of technology on the
future
References
1.
2.
3.
4.
5.
6.
7.
8.
Rex DK, Heuss LT, Walker JA, Qi R. Trained registered nurses/endoscopy
teams can administer propofol safely for endoscopy. Gastroenterology
2005; 129(5):1384-1391.
Weaver JM. The great debate on nurse-administered propofol sedation
(NAPS) – Where should we stand?
Anesthesia Progress, Summer 2006;
53(2):31-33.
Rex DK, et al. Endoscopist-directed administration of propofol: A worldwide
safety experience. Gastroenterology, 2009; 137(4):1229-1237.
Cote GA, et al. Incidence of sedation-related complications with propofol
use during advanced endoscopic procedures. Clinical Gastroenterology
and Hepatology, 2010; 8(2):137-142.
Metzner J, Domino KB. Risks of anesthesia or sedation outside the
operating room: the role of the anesthesia care provider. Curr Opin
Anaesthesiol. 2010; 23(4):523-31.
Ootaki C et al. Does general anesthesia increase the diagnostic yield of
endoscopic ultrasound-guided fine needle aspiration of pancreatic
masses? Anesthesiology. 201; 117(5):1044-50.
Rex DK. The Science and politics of propofol. Am J Gastroenterol, 2004;
99(11):2080-3.
Gervirtz. Nurse-administered propofol regularly puts patients
at risk. Gastroendonews, 2005, May.
Questions?