Transcript Controversies in Procedural Sedation and Induction in ER

Controversies in Procedural
Sedation and Induction in ER
February 2004
Controversies
REVIEW OF ANESTHESIA
GUIDELINES
 IS ETOMIDATE SAFE FOR ER
INDUCTION?
 IS PROPOFOL SAFE IN CHILDREN?
 IS KETAMINE SAFE IN HEAD INJURED
PATIENTS?
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ANESTHESIA GUIDELINES
PRACTICE GUIDELINES FOR
SEDATION AND ANALGESIA BY NONANESTHESIOLOGISTS ANESTHESIOLGY 2002
 GUIDELINES FOR MONITORING AND
MANAGEMENT OF PEDIATRIC
PATIENTS DURING AND AFTER
SEDATION –ADDENDUM PEDIATRICS 2002
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ANESTHESIA GUIDELINES
ASA 2002
 AAP 2002
 EVIDENCE BASED CONSENSUS
OPINION TASK FORCE
 CAEP 1999
 ACEP 1998
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PEDIATRIC ADDENDUM
DOCUMENTED PRESEDATION
MEDICAL EVALUATION
 APPROPRIATE FASTING INTERVAL
 SKILLED PERSONNEL
 PULSE OXIMETRY
 ASSIGNED MONITORING INDIVIDUAL
 SPECIFIC DISCHARGE CRITERIA
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ASA PRACTICE GUIDELINES
DEFINTION SEDATION DEPTH
 PRE PROCEDURE ASSESSMENT
 PRE PROCEDURE FASTING
 MONITORING / CAPNOGRAPHY
 ANCILLARY STAFF
 MEDICATIONS
 RECOVERY CARE/DISCHARGE
CRITERIA
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LOCAL ANESTHESIA
CONCERNS
GENERAL ANESTHESIA IN ER
 POOR DOCUMENTATION
 PRE PROCEDURE ASSESSMENT
 POST PROCEDURE RECOVERY
 DISCHARGE CRITERIA
 EDUCATIONAL PROCESS
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DEPTH OF SEDATION
Sedation Response Airway
Vent
CVS
Moderate purpose
normal
normal
normal
Deep
Repeated Possible Possible Usually
painful
intervene abnormal normal
General
anesth
No
Often
Frequent Maybe
response intervene abnormal abnormal
Sedation Depth
Conscious Sedation removed
 Dissociative Sedation not classified
 All sedatives and narcotics can produce all
levels of sedation ,some are more likely to
induce deep or general anesthesia
 Deep and general anesthesia are more likely
to be associated with adverse reactions
 Sedation depth difficult to measure
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PRE PROCEDURE
EVALUATION
Guided RiskAssessment Tool
 Snoring, Stridor Sleep apnea
 Airway abnormalities
 Vomiting, bowel obstruction
 Gastroesophageal reflux
 ASA class
 Sedation Failure
 NPO status
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HOFFMAN PEDS 02
PRE PROCEDURE FASTING
REQUIREMENTS
ASA GUIDELINES
 Liquids
2 hours
 Breast milk 4 hours
 Solids
6 hours
 NO SCIENTIFIC EVIDENCE TO
SUPPORT THIS CONSENSUS OPINION
 TRACHEA and ESOPHAGEAL
PROCEDURES NOT ROUTINE IN ER
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PRE PROCEDURAL FASTING
ASPIRATION RISK
 NO Published aspiration in ER> 30 years
 Risk of aspiration ~1/895 emergency
surgery and ~1/3500 surgery
 Two thirds aspiration during intubation
 Increased incidence of sedation failures
with prolonged fasting times
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FASTING LITERATURE
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Pre procedural fasting adverse events ER
Agarwal et al Annals of Emergency Medicine 2003
Pediatrics prospective case series n=905
 Adverse events minor 8.1%* incidence in
compliant and 6.9%* in noncompliant
 Emesis 1.5%
 Medications ketamine/midazolam
fentanyl/midazolam
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FASTING LITERATURE
Median fasting duration solids 9.6 *hours vs
5.2 hours non compliant
 Median fasting duration clear liquids 8.5
hours vs 4.7* hours non compliant
 CONCLUSION There was no association
between preprocedural fasting state and
adverse events
 ????? What?
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Preprocedural Fasting
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ACEP recent food intake is not a contraindication
for administering PSA but should be considered in
choosing the depth and target level of sedation
CAEP Urgency of procedure and desired depth
of sedation should be weighed against the risk
associated with inadequate fasting
ASA potential for aspiration must be considered
in determining target sedation level, or whether to
delay or protect by intubation
???
MONITORING
Level of consciousness
 Oxygenation
 Hemodynamics
 Ventilation* capnography
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Ventilation Capnography
ASA-- capnography may decrease risks
during deep sedation
 Capnography may decrease risks during
moderate and deep sedation when patient
physically separated from caregiver
 Supplemental oxygen decreases patient risk
during deep sedation
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Capnography
Measurement of endtidal CO2 infrared
spectroscopy nasal cannulae
 Not as accurate as in intubated patients
 No evidence to suggest that it will reduce
complications but may alert to subclinical
respiratory depression
 Respiratory depression- ETCO>50, increase
>10 from baseline, absent waveforem
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Capnography Literature
6 studies in ER literature
 Propofol 19-48% resp depression on
supplemental 02
 Ketamine 6% RD no O2
 Methohexital 48% RD on 02
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Capnography
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MAYBE*
Deep sedation may require supplemental 02
Propofol sedation often deep or general
Supplemental 02 may limit oximetry utility
GREEN AND KRAUSS*
Krauss paid consultant for capnography company
Green – “Propofol not ready for prime time 1999”
Green– Propofol ready for prime time 2003 –
three* studies later
Ancillary Staff
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Trained individual other than the practitioner
should be monitoring patient
CRHA monitored continuously during procedure
by RN with or without RT
Airway
Oxygenation
Level of consciousness
Pain
General Status
Ancillary Staff
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CRHA - RN or LPN with or without RT
monitor immediately post procedure and
within 15 minutes the same parameters and
vital signs
Medications
Combination of sedative/analgesic increase
risk of complications
 Efficacy of sedative alone unknown*
 Propofol/methohexital use consistent with
deep or general anesthesia
 Etomidate not described but deep and
general anesthesia common
 Ketamine difficult to classify
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Recovery Care Discharge Criteria
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D/C when able?
ASA ---monitored until they are near baseline
level of consciousness and are no longer at
increased risk for cardiorespiratory depression
ACEP return to pre procedure baseline
CAEP Airway patency, ventilation,cvs and
hydration satisfactory
Level of consciousness returned to baseline
Sit unassisted,* tolerate oral fluids
Recovery Care / Discharge
Criteria
Insufficient literature on topic
 Based on post operative Aldrete* scoring
system
 Activity respiration circulation
consciousness and skin color max 10
 MPADSS– modified post anaesthetic score
 Vital signs ambulation nausea pain bleeding
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Recovery Care/Discharge
Criteria
“Street Fitness” or home readiness is also
poorly defined
 ACEP --no activity that requires
coordination for 24 hours
 CAEP-- no coordination activity for 12
hours, no food or drink for two hours,
observe child closely for 8 hours
 Medication dependent/hospital dependent
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Recovery Care Literature
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When is a Patient Safe for Discharge After
Procedural Sedation ?Newman et al Annals of
Emergency Medicine 2003
Prospective data base 2 years 1341
sedations adverse events 13.7%
 Ketamine/midazolam fentanyl/midazolam
 Conclusions– discharge from ED may be
safe ~30 minutes after final medication
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Recovery Care Literature
No discharge criteria in place
 Follow up patients poor 64%
 Serious adverse effects occurred median 2
minutes post final med but up to 40 minutes
post med
 Clearly cannot generalize data
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Guidelines/Anaesthesia?
Preprocedure assessment
 Pre procedure preparation fasting
 Monitoring people equipment
 Drug selection- sedation depth
 Post procedure care
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Is Etomidate Safe for ER
Induction?
Unknown
 Adrenal suppression—1983 increased
mortality in ICU 40% with etomidate
infusion cause infection postulated to be
adrenal suppression
 Multiple studies confirm adrenal
suppression in infusions and single doses
 Clinical implication unclear
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Etomidate literature
Adrenocortical Dysfunction following
Etomidate Induction in ER Schenarts et al Academic
emergency medicine 2001
Prospective randomized controlled n=18
 Etomidate vs midazolam RSI measuring
cortisol response to CST testing 4-24 hours
 Conclusions: etomidate in ED RSI results
in adrenocortical dysfunction which appears
to resolve in 12 hours
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Etomidate literature
Important study but serious flaws
 Data collection errors methodology
questionable
 Reporting of data concerning
 Of note: hours intubated 68.6 etomidate
28.4 midazolam ----hours in ICU 96.8
etomidate ,42 midazolam
 Leaves question unanswered
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Etomidate Literature
NEAR study-- 60% intubations etomidate
suggesting higher dose for success
 Need another study to address impact of
etomidate in ER on ICU outcome
 Adrenal suppression increased mortality in
adult ICU patients and increased
vasopressor use in pediatric patients
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Etomidate Literature
PROCEDURAL SEDATION 6 studies 5
ER
 Mainly retrospective small numbers
 Myoclonus 2-20%
 Vomiting 2-10%
 Hypoxia 10%*
 Hypotension 2-5%
 Deep sedation was frequent when recorded
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IS PROPOFOL SAFE in
CHILDREN?
Propofol infusion syndrome FDA health
warning 2001*
 CMAJ 2002 Wooltorton significant harm
can come from off-label use of agents
whose pediatric safety profile is
incomplete*
 Large dose propofol affects cerebral
autoregulation --caution in head injured
patients Anesth Analg 2003
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Safety of Propofol in Pediatric
Procedural Sedation
5 published ER studies*
 Propofol hypoxia 5%-30%**
 Hypotension 5%-30%**
 Troubling Methodology
 Supplemental oxygen
 Blood pressure measurement skewed
 Adverse events altered definition
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Propofol Literature
Propofol for Procedural Sedation in
Children in the ER Basset et al Annals of ER 2003
 Consecutive case series n=392
 92% transient hypotension
 5% hypoxia 3% jaw thrust 1%bvm
 Conclusion: efficacious no adverse
outcomes
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Propofol Literature
Preoxygenation 10L/min
 Blood pressure change = post sedation
blood pressure- minimum
 ~80 patients had blood pressure drop of >20
six required iv fluids
 ~80 patients dropped 02sat>5% after
preoxygenation
 Four member team
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Propofol literature
Propofol vs Ketamine in pediatric critical
care Vardi et al Critical Care Medicine 2002
 Prospective randomized n=105
 Propofol vs Ketamine midazolam fentanyl
 Propofol 2.5mg/kg vs Ketamine 2.5mg/kg/
midazolam 0.1mg/kg fentanyl 2ug/kg
 SIGNIFICANT DIFFERENCE ADVERSE
EFFECTS REQUIRING INTERVENTION
WITH PROPOFOL
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Propofol Safety
Clearly there are safer drugs than propofol
 Does a little hypoxia and or hypotension in
a monitored setting give rise to concerns if
the drug is efficacious and efficient?
 Proceed with caution
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Is Ketamine Safe in Head Injured
Patients?
MAYBE
 Historically ketamine was used for
neurodiagnostic sedations in hundreds of
patients in 60’s and 70’s with no sequelae
 1972-1974 small case series with varying
doses of ketamine and variable monitoring
devices variable ICP demonstrate elevation
in ICP mean~increase 30 no sequelae
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Ketamine Head Injury
Case series during similar era, similar
method and design demonstrate that
intubation, inhalational anesthetics and
succinylcholine lead to ~increase ICP 25
Clinical implications of brief rise in ICP in
already elevated ICP was and still unclear
Ketamine Head Injury
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1974-2003 small prospective randomized studies
done with intravenous ketamine for sedation on
ventilated head injured patients
No change or significant improvement in ICP
No change in cerebral perfusion pressure
Decrease in cerebral blood flow velocity
Decrease in EEG power
Maintains cerebral autoregulation
Ketamine Head Injury
Ketamine effects on cerebral hemodynamics
poorly understood
 May or may not increase regional cerebral
blood flow but minimal effects on
metabolism
 Increases neuronal activity
 May have a neuroprotective effect as a
NMDA antagonist
 S+isomer may have less cerebral effects
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Ketamine Head Injury
Maybe
 It is all about Numbers and not Outcome
 Are transient decreases in MAP and CPP
with thiopentothal or midazolam worse or
better than transient increases in MAP and
ICP with ketamine?
 Who Cares? Patient profile
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Controversies Sedation and
Induction in ER
Multiple medication options
 Significant potential adverse effects with
most meds but few significant
complications
 Literature relatively weak in design and
numbers with multiple manipulations of
data
 Significant pharmaceutical money at stake
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Controversies
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Safety is paramount*-- enhance with drug
knowledge, preprocedure assessment, monitoring
and discharge criteria
Efficacy is important but sedation depth is poorly
defined and measured
Efficiency is important but cannot preclude safety
and efficacy
Medicolegal concerns necessitate improved
documentation
Ideal Drug?
Controversies
??????