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WillAnesthesiologistsBeReplacedbyaMachine?
BretS.Stetka,MDJeffreyApfelbaum,MDDanielJ.Pambianco,MD |September22,2015
Editor'sNote:
Inrecentmonths,afewhospitalsintheUnitedStateshavebegunusinganautomatedanesthesiologymachine
calledtheSedasyscomputerassistedpersonalizedsedation(CAPS)system(EthiconUS,LLCSomerville,New
Jersey)toprovidesedationinroutinecolonoscopiesandendoscopyprocedures.ThedeviceisthefirstandonlyUS
FoodandDrugAdministration(FDA)approvedCAPSproduct,andsomeanesthesiologistshaveexpressedconcern
thatit'saftertheirjob.MedscaperecentlyconductedemailinterviewswithDanielJ.Pambianco,MD,a
gastroenterologistbasedinCharlottesville,Virginia,whoservedastheleadinvestigatoronthepivotalstudyleading
toitsapproval,andJeffreyApfelbaum,MD,professorandchair,DepartmentofAnesthesiaandCriticalCare,
UniversityofChicago,Chicago,Illinois,andcochairoftheAmericanSocietyofAnesthesiologists(ASA)committee
ontheSedasysmachine,abouthowCAPStechnologymightinfluencethepracticeofanesthesiologyand
gastroenterology.

Medscape:HowdoestheSedasysmachinework?

DrApfelbaum:TheSedasysSystemisthefirstofaclassofCAPSdevices.IthasbeenapprovedbytheFDAto
administerpropofolandoxygenfortheinitiationandmaintenanceofminimaltomoderatesedationinveryhealthy
adultpatients(ASAIandIIpatients)undergoingeitherroutinecolonoscopyorroutineupperendoscopyprocedures.
Thedevicelimitsthedepthofsedationbymonitoringseveralphysiologicparameters,includingpatient
responsivenesstoanautomatedresponsedevice,wherebythepatientsqueezesahandheldswitchinresponseto
computergeneratedcues.Thedevicealsocontainsalarmstoalertmedicalprofessionalsofpossibleconcerns.

DrPambianco:Sedasysisacomputerassistedsedationdevicethatintegratesphysiologicmonitoringofthepatient
whiledeliveringpropofol.Itallowstheendoscopist/nurseteamtotitratedrugdeliverytominimaltomoderatelevels
ofsedationwhilepreventingoversedation.Thedeviceusesanalgorithmofpropofoldosingbycontinuousinfusion
controlledbythephysician/nurseteamtoachievethelevelofsedationtokeepthepatientcomfortableforthe
specificendoscopicprocedure.Thedeviceassiststheteaminmonitoringthepatient,givingphysiologic
assessmentseveryfewseconds,andpreventsoversedationbyalertingtheteamifoxygendesaturationorapneais
occurring.Thedevicewillautomaticallyincreaseoxygendeliveryinresponsetosuchevents,alerttheteam,and
eventuallydecreaseorstoptheinfusionofpropofoliftheeventsarenotcorrectedbytheteam.Onlytheteamcan
restartthepropofolinfusiononcetheeventsareaddressed.

Medscape:Whatarepotentialadvantagesofthismachinecomparedwithanesthesiologistdeliveredcare?

DrApfelbaum:Manypatientsrequiresedationwhileundergoingcolonoscopyandesophagogastroduodenoscopy
(EGD).Gastroenterologistsmaychoosetoadministersedationwithoutaphysiciananesthesiologistduringthese
procedures,andinthesecasestheytypicallyadministeracombinationofbenzodiazepinesandnarcotics.Inspiteof
thefactthatbothbenzodiazepinesandnarcoticshavespecificrapidactingreversalagents,undercertain
circumstances(eg,failuretorecognizehypoxiaorcardiovascularcollapse,failuretorecognizeovermedication,etc.)
catastrophiceventssometimesoccurduringtheprocedure.Thepivotalstudy[1]forthisdevicedemonstratedthat
healthypatientswhoweresedatedusingthedevicehadloweroccurrencesofhypoxemiacomparedwithsimilarly
healthypatientswhoreceivedbenzodiazepinesorsimilarmedicationsforthesameprocedures.

DrPambianco:Thevastmajorityofroutineendoscopyrequiresminimaltomoderatesedation,whichcanbe
achievedsafelywiththedevice.Recentheadtoheaddatahaveshownmoreefficientdosingofpropofolandless
unintendeddeepersedationwiththedevicecomparedwithanesthesiologistsforroutineendoscopy.Inadditionand
mostpertinentisthefactthatthereareinsufficientnumbersofanesthesiaproviderstoadministerpropofolforallof
theendoscopiesperformedintheUnitedStates.

Medscape:Whatdisadvantagesdoyouseeassociatedwiththemachine?

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DrApfelbaum:WhiletheSedasysSystemcansafelyadministersedationforhealthypatientsundergoingthe
proceduresmentioned,emergenciescananddooccur,evenduringthesimplestproceduresandwiththehealthiest
patients.UnlikeaCAPSdevice,aphysiciananesthesiologistcanandwillintervenetosavethepatientinthese
emergencysituations.Additionally,manyhaveconcernsforthesafetyofpatientsifdeviceoperatorsdonotremain
instrictcompliancewiththelimitationsimposedbytheFDAontheuseofthedevice(eg,patientselection,fulfillment
andmaintenanceofskillsfromthespecificeducationalandsimulationrequirements,immediateavailabilityofa
trainedanesthesiaprofessional).

Toaddresstheseandotherconcerns,ASAhasissuedaguidancedocumentonCAPSdevicesthatprovides
specificclinicalandadministrativerecommendationsfordirectorsofanesthesiaservicesthatwillservetooptimize
safeuseofthedevice.

DrPambianco:CurrentlythedeviceisFDAapprovedforASAI/IIpatientsforroutineendoscopy,whicharethe
majorityofprocedures.ItisnotapprovedforASAIIIpatientsorforproceduresrequiringlongersedation.Another
limitationisforpatientswhowillrequiredeepersedationforroutinecolonoscopyorEGDsuchaspatientsonchronic
painmedsorpatientswhoabusealcohol.

ShouldAnesthesiologistsBeWorried?
Medscape:DoyouthinktheSedasysmachinewill,atleastinsomecases,replacetheanesthesiologist?

DrApfelbaum:Basedonmyreadingsofthepivotalstudy,theinformationprovidedbytheFDA,andother
preliminarypublications,IbelievethisCAPSsystemcansafelyadministersedationforhealthypatientsundergoing
routinecolonoscopyandupperendoscopyprocedureswhenthedeviceisusedincompliancewiththelimitations
imposedbytheFDA.

However,notechnology,includingtheSedasysSystem,canreplaceaphysician.Thoughitmayidentifyaproblem
anddecreasetheadministrationofongoingsedation,itisincapableofrescuingapatientincrisis.Asmentioned
previously,acatastrophiceventcanoccurduringsimpleproceduresevenwiththemosthealthypatients.Physician
anesthesiologists,unlikeaCAPSdevice,canandwillintervenetosavethepatientintheseemergencysituations.
Recognizingthis,thedevicelabelrequiresthatananesthesiaprofessionalbeimmediatelyavailableforassistance
orconsultation,whichmeansthattheymustbeavailabletorespondtoemergencysituations.

GiventheextremelylimitedsafetyindicationforthisCAPSdevice,physiciananesthesiologistswillcontinueto
providecareinthevastmajorityofcaseswherepatientshaveanydegreeofsignificantillnessandforallcases
wheredeepsedationorgeneralanesthesiaisrequired.Intheircapacityasdirectorsofanesthesiaservices,
physiciananesthesiologistswillalsoserveapivotalrolewiththeintroductionanduseofCAPSdeviceswithin
healthcarefacilities.CentersforMedicare&MedicaidServicesconditionsofparticipationrequirethatthedirectorsof
anesthesiaservicesberesponsibleforallanesthesiaandsedationadministeredinahospital,whichincludes
sedationadministeredbyCAPSdevices.

InthecaseofSedasys,thedirectorsofanesthesiaserviceswillworkcloselywiththedirectorsofgastroenterology
servicestointegratethisdevicesafelyintogastroenterologypracticefortheseroutineproceduresinveryhealthy
patients.

DrPambianco:Giventhecurrentmandatetoincreasecoloncancerscreeningto80%aswellasothergrowing
usesforscreeningendoscopyandtheproliferationofpropofoluseforsedation,duetoitsbenefits,thereare
insufficientanesthesiaproviderstomeetthesedemands.Currentlyoutsideofambulatoryendoscopyunits,the
abilityofanesthesiatoprovideservicestoendoscopyunitsislimited,particularlyinhospitalsandsmaller
gastrointestinalpractices.Therefore,Idonotbelievethatthedevicewillreplaceanesthesiologistsbutenhancethe
abilitytoprovidemoreeffectiveandsafersedationforourpatients.

References

1. PambiancoDJ,VargoJJ,PruittRE,HardiR,MartinJF.Computerassistedpersonalizedsedationforupper
endoscopyandcolonoscopy:acomparative,multicenterrandomizedstudy.GastrointestEndosc.
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201173:765772.Abstract

MedscapeAnesthesiology2015WebMD,LLC

Anyviewsexpressedabovearetheauthor'sownanddonotnecessarilyreflecttheviewsofWebMDorMedscape.

Citethisarticle:WillAnesthesiologistsBeReplacedbyaMachine?Medscape.Sep22,2015.

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