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REVISTA

BRASILEIRA

DE

ANESTESIOLOGIA

OfficialPublicationoftheBrazilianSocietyofAnesthesiology

www.sba.com.br

SCIENTIFIC

ARTICLE

Use

of

positive

pressure

in

pre

and

intraoperative

of

bariatric

surgery

and

its

effect

on

the

time

of

extubation

Letícia

Baltieri,

Laisa

Antonela

dos

Santos,

Irineu

Rasera-Junior,

Maria

Imaculada

de

Lima

Montebelo,

Eli

Maria

Pazzianotto-Forti

MastersPrograminPhysicalTherapy,UniversidadeMetodistadePiracicaba(UNIMEP),Piracicaba,SãoPaulo,Brazil

Received23August2013;accepted31October2013 Availableonline8January2015

KEYWORDS Diseases; Obesity;

Bariatricsurgery; Ventilation:positive pressure

Abstract

Backgroundandobjective: Toinvestigatetheinfluenceofintraoperativeandpreoperative

pos-itivepressureinthetimeofextubationinpatientsundergoingbariatricsurgery.

Method: Randomizedclinicaltrial,inwhich40 individualswithabodymassindexbetween

40and55kg/m2,agebetween25and55years,nonsmokers,underwentbariatricsurgerytype

Roux-en-Ygastricbypassbylaparotomyandwithnormalpreoperativepulmonaryfunctionwere randomizedintothefollowinggroups:G-pre(n=10):individualswhoreceivedtreatmentwith noninvasivepositivepressurebeforesurgeryfor1h;G-intra(n=10):individualswhoreceived positiveend-expiratorypressureof10cmH2Othroughoutthesurgicalprocedure;andG-control

(n=20):notreceivedanypreorintraoperativeintervention.Followingwererecorded:time betweeninductionofanesthesiaandextubation,betweentheendofanesthesiaandextubation, durationofmechanicalventilation,andtimebetweenextubationanddischargefromthe post-anestheticrecovery.

Results:Therewas nostatisticaldifferencebetween groups.However,when appliedtothe

Cohen coefficient,the useofpositive end-expiratory pressure of10cmH2Oduringsurgery

showedalargeeffectonthetimebetweentheendofanesthesiaandextubation.Aboutthis sametime,thetreatmentperformedpreoperativelyshowedmoderateeffect.

Conclusion:The use ofpositive end-expiratory pressureof10cmH2Ointhe intraoperative

andpositivepressurepreoperatively,influencedthetimeofextubationofpatientsundergoing bariatricsurgery.

©2014SociedadeBrasileiradeAnestesiologia.PublishedbyElsevier EditoraLtda.Allrights reserved.

Correspondingauthor.

E-mail:[email protected](E.M.Pazzianotto-Forti). http://dx.doi.org/10.1016/j.bjane.2013.10.021

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PALAVRAS-CHAVE Doenc¸as;

Obesidade; Cirurgiabariátrica; Ventilac¸ãomecânica: pressãopositiva

Utilizac¸ãodapressãopositivanopréenointraoperatóriodecirurgiabariátricae seusefeitossobreotempodeextubac¸ão

Resumo

Justificativaeobjetivo: Investigar ainfluênciado usoda pressãopositiva intraoperatóriae

pré-operatórianotempodeextubac¸ãodepacientessubmetidosàcirurgiabariátrica.

Método: Trata-sedeensaioclínicorandomizado,noqual40indivíduoscomíndicedemassa

corporal entre40e55kg/m2,idadeentre25e55anos,nãotabagistas,submetidosà

cirur-gia bariátrica do tipo derivac¸ão gástrica em Y de Roux por laparotomia e com prova de func¸ão pulmonar pré-operatória dentro da normalidade foram randomizados nos seguintes grupos:G-pré (n=10):indivíduosquereceberamtratamentocompressãopositiva não inva-sivaantesdacirurgia,duranteumahora,G-intra(n=10):indivíduosquereceberamPositive End-expiratory Pressure de10cm H2O durantetodo oprocedimento cirúrgico e G-controle

(n=20):nãoreceberamqualquertipodeintervenc¸ãopréouintraoperatória.Foramanotados osseguintestempos:tempodecorridoentreainduc¸ãoanestésicaeaextubac¸ão,entreo tér-minodaanestesiaeextubac¸ão,tempodeventilac¸ãomecânica,etempoentreaextubac¸ãoe aaltadaRecuperac¸ãoPós-Anestésica.

Resultados: Nãohouvediferenc¸aestatísticaentreosgrupos,porémquandoaplicadoao

Coe-ficientedeCohen,ousodaPositiveEnd-expiratoryPressurede10cmH2Onointraoperatório

mostrouumefeitograndesobreotempoentreotérminodaanestesiaeaextubac¸ão.Sobre estemesmotempo,otratamentorealizadonopré-operatórioapresentouefeitomoderado.

Conclusão:Ouso daPositiveEnd-expiratoryPressure de 10cmH2Onointraoperatórioe da

pressãopositivanopré-operatório,podeinfluenciarotempodeextubac¸ãodepacientes sub-metidosàcirurgiabariátrica.

©2014SociedadeBrasileira deAnestesiologia.PublicadoporElsevierEditoraLtda.Todosos direitosreservados.

Introduction

Obesityiscurrentlyconsideredapublichealthproblemthat is reaching epidemic proportions.1 In 2008, over 1.4 bil-lionadultswereoverweightand,ofthese,over200million men and nearly300 million women were obese.1 Consid-eredtobeofmultifactorialorigin,theprobablecausesof obesityincludeacombinationofgenetic,endocrine, behav-ioral, socioeconomic, psychological, and environmental imbalances and,consequently,the emergence ofmultiple comorbidities.2Conservativetreatmentinvolvesnutritional therapy,drugtherapy,andphysicalactivity.When conserva-tivetreatmentisunsuccessfulandobesitybecomesmorbid, thebariatricsurgeryisindicated.3

Most surgical procedures requiring general anesthesia maytriggertheonsetofpostoperativecomplications,such as atelectasis, due to a decrease in functional residual capacity (FRC).4 Moreover, the loss of abdominal muscle integrity due tothe incisionand the need for neuromus-cularblockers,sedatives,andanalgesicsalsointerferewith musclecontractility,whichinturntriggerstheinadequate respiratorymuscleperformanceaftersurgery.5

Theseeffectsofgeneralanesthesiawhenassociatedwith morbid obesity may further worsen the development of intraoperativeandpostoperativecomplications.6Thus,the longerthedurationofsurgery,andconsequentlythe anes-theticprocedure,thegreaterthechancesofpostoperative pulmonarycomplications.7

Respiratoryphysiotherapywithre-expansiontechniques has proven benefits in reducing complications after

abdominalsurgery,8 but there are nowell-designed clini-caltrialsintheliteraturetoprovethatthereissuperiority betweenthe proposedtreatment formsfor the preopera-tive,intraoperativeandpost-operativeperiodsofabdominal surgery.

Literatureontheuseofnoninvasivemechanical ventila-tionpostoperativelyisvastandshowsgoodresults.9---11Some ventilatorystrategieshavebeenusedpostoperativelyinan attempttoimprovegasexchangethroughtheuseofpositive pressuremaneuversaimingatalveolarrecruitmentandeven reducingthesurgical time.12,13 However,theliterature on theuseofpositivepressurepreoperativelyasaprophylactic mannerisstillscarce.

Thus,thehypothesisofthestudywasthatpositive pres-sure applied during both pre- and intraoperative periods mayinfluencethe extubationtimeof patients undergoing bariatricsurgery.

Therefore, the aim of this study was to investi-gate the influence of intraoperative 10cm H2O positive

end-expiratory pressure (PEEP) and preoperative positive pressureonextubation timeof patientsundergoing Roux-en-Ygastricbypassbariatricsurgery.

Method

Studydesign

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under protocol 54/11, and all patients provided written informedconsent.

Participants

Individuals with body mass index (BMI) between 40 and 55kgm−2,agedbetween25and55years,undergoing

Roux-en-Y gastric bypass bariatric surgery by laparotomy, and with normal preoperative pulmonary function tests were included.Smokersorthosewithhemodynamicinstabilityor surgicalcomplicationswereexcluded.

Samplesizecalculation

The sample size calculation was based on a pilot study, consideringthedifferenceoftheexpiratoryreservevolume (ERV)valuesobtainedbetweenthepreoperativeand postop-erativeperiods.Theleastsignificantdifference(0.18L)and theerrorstandarddeviation(0.11L)wereusedforthe cal-culation.ANOVAtestwasused,adoptingastatisticalpower of80%andan alphaof 0.05.Thus,anumberof 10 volun-teerspergroupwasdetermined.Samplesizecalculationwas performedusingtheBioEstatsoftwareversion5.3(Belém, Brazil).

Investigators

Thestudy included threeresearchers:oneresponsible for the patient initial evaluation and inclusion, one blind to initial data of volunteers and responsible for randomiza-tion,andone responsiblefortreatment application.After patient eligibility, randomization was performed and a sealedenvelopewashandedtotheinvestigatorresponsible fortreatmentapplication.

Screeningofvolunteers

Theinitialscreeningofvolunteerswasperformedby search-ingthepatientregistrationformforpossibleinclusioninthe study.Volunteersweredividedintothreedifferentgroups afterrandomizationinblocksoffiveusingMicrosoftExcel®

software.

Treatmentapplication

Subjectsinpreoperative group (PO)group received treat-mentwithbilevelpositiveairwaypressure(BiPAPSynchrony II---Respironics®)viafacialmaskforonehourbeforesurgery.

Theinspiratorypositiveairwaypressure(IPAP)wasstarted at12cmH2Oandadjustedaccordingtotheindividual

tol-erance, maintaining a respiratory rate below 30 breaths perminuteandatidalvolumeabout8---10mLkg−1ofideal

weight.Positiveend-expiratorypressure(PEEP)wassetat 8cmH2O.

Subjects in intraoperative group (IO) group received 10cmH2OPEEPthroughoutthesurgicalprocedure.

Subjects in control group received no preoperative or intraoperativeintervention.

All patients underwent bariatric surgery performed by the same surgical team under general anesthesia and

standard ventilation withtheDräger FabiusGS ventilator, involumecontrolmode,withtidalvolumeof6---8mLkg−1,

PEEP of 5cm H0O (except for IO group), and fraction of

inspiredoxygenbetween0.4and0.6.

Procedures

Respiratory evaluation consisted of anthropometric data collectionandpulmonaryfunctiontestbyspirometer micro-QuarkPony-FC(Cosmed,Rome,Italy).

Spirometrywasperformedinaccordancewithstandards oftheAmericanThoracicSociety(ATS)andEuropean Respi-ratory Society (ERS).14 Volunteers withnormal pulmonary functionwereincludedinthestudy.

Patientswerefollowed-upbytheinvestigatorinthe oper-ating room,and thesurgical procedure wasperformed as follows:thepatientpositionedonthesurgicaltablewas sub-jectedtoinductionofanesthesiawithinhaled sevoflurane andintravenouspropofol,andanesthesiamaintenancewith remifentanilby continuousinfusion pump.Afterinduction ofanesthesia,thepatientunderwentorotrachealintubation andwasplacedonmechanicalventilation.Bariatricsurgery began with a midline incision in the upper abdomen and duringthesurgicalprocedurethepatientwastreatedwith neuromuscularblockers andanalgesics,accordingtoneed evaluated by the surgeon and the anesthesiologist. After surgery, remifentanil was discontinuedand considered as theend ofanesthesia. Subsequently,thepatientcouldbe extubatedandtransferredtothepost-anesthesiacareunit (PACU)usingoxygenmask.Ascoreof10ontheAldreteand Kroulikscale,15 usedashospitalprotocol,wasrequiredfor patientdischargefromPACU.

Outcomemeasurements

The following outcomes were recorded during surgical procedure:timebetweeninductionofanesthesiaand extu-bation,timebetweentheendofanesthesiaandextubation, timeofmechanicalventilation,andtimebetween extuba-tionandPACUdischarge.

Statisticalanalysis

The SPSS version 17.0 was used for statistical analysis. Quantitative data are presented as mean and standard deviation(SD)andqualitativedataasfrequencies.Not sat-isfiedtheassumptionofnormalityandhomoscedasticityby Shapiro---WilkandLevene’stests,theKruskal---Wallistestwas performed.A5%levelofsignificancewasconsidered.

Treatment influence on variables was tested using an effectsizetocomparetreatmentgroupswithcontrolgroup. Forthis,theCohen’sdpooledorweightedwasused.

Cohen’s d pooled is calculated as follows: Cohen’s

d=mean 1−mean 2weighted SD−1, with weighted

SD=(SD1+SD2)2−1.

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Surgical patients (n=271) Excluded (n=228)

Excluded (n=3)

Inability to evaluate: hospital routine (n=147)

Laparoscopic surgery (n=40)

Asthma (n=11) Smoking (n=9)

COPD (n=1) Age <25 years (n=1)

Age >55 years (n=1)

Another surgical type (intragastric balloon, revision, etc.) (n=4) BMI <40 kg.m–2 (n=12)

BMI >55 kg.m–2 (n=2)

Evaluated and randomized (n=43)

PO group (n=10) IO group (n=13)

PO group (n=10) IO group (n=10)

BMI: Body Mass Index; COPD: chronic obstructive pulmonary disease; OTI: orotracheal intubation; BE: bronchospasm.

Control group (n=20) Control group

(n=20)

Difficult TI + BE (n=1)

Surgical

complications (n=2)

Figure1 Flowchartofpatientsincluded.

Results

Within 20 weeks of the study, 271 patients under-went surgery, and of these, 228 were excluded for not meeting the criteria previously established. Forty-three patients were evaluatedand, of these, three were excluded during the study, leaving 40 patients: 20 in control group, 10 in IO group, and 10 in PO group (Fig.1).

Table1showstheanthropometriccharacteristicsof vol-unteers,withnostatisticaldifference,indicatingthesample homogeneity.

Table 2 summarizes the findings regarding intraopera-tivemeasurements,withnostatisticaldifferencesbetween groups.

Table3summarizesthevaluesobtainedfromthe treat-menteffectsizeanalysisusingCohen’scoefficient applied to the duration of surgery variables, revealing that the

Table1 Age,gender,andanthropometricdataofgroups,presentedasmeanandstandarddeviation.

Control IO PO p

n 20 10 10

Sex(F/M) 16/4 9/1 8/2 0.773

Age(years) 40.7±10.6 37.3±11.4 42±11.2 0.622

Weight(kg) 120.8±20.26 119.7±17.8 120.9±17.0 0.894

Height(cm) 162±27.7 163.1±8.2 163.9±9.07 0.973

BMI(kgm−2) 45.72

±4.08 44.8±4.7 44.8±2.8 0.534

Idealbodyweight(kg)a 60.59±4.52 60.6±4.9 60.9±6.1 0.980

F,female;M,male;BMI,bodymassindex;IO,intraoperativegroup;PO,preoperativegroup.

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Table2 Timepointspresentedinminutes.

Timepoint Mean±SD

Control IO PO p

n 20 10 10

Inductionofanesthesia---extubation 132.2±12.71 128.5±14.3 131±14.2 0.58

Endofanesthesia---extubation 23.8±7.85 17±6.74 19.3±6.2 0.07

MVtime 128.4±12.03 126.2±13.9 127.3±14.2 0.65

Extubation---PACUdischarge 213.5±65.7 249.5±77.8 218.4±83.1 0.52

SD,standarddeviation;MV,mechanicalventilation;PACU,post-anesthesiacareunit;IO,intraoperativegroup;PO,postoperativegroup.

intraoperativePEEPapplicationshowedgreateffectonthe timebetweentheendofanesthesiaandextubation,aswell asthepreoperative application of positivepressure, with moderateeffect.

Discussion

Results show that there was no statistical difference betweengroupswhentherespectivetimeswereevaluated. However, when applied to the Cohen coefficient, which evaluates the treatment effect, the preoperative use of 10cmH2O PEEP showedalarge effectonpatient

extuba-tiontimefromtheend of anesthesia. Thus,patients who haveundergone thistreatment reducedthe timespentin trachealintubation.Regardingthissametime,the preoper-ativetreatmentshowedmoderateeffect.

Among the respiratory changes resulting from obesity, theobeseindividualpresentschangesinbreathing mechan-ics,decreased respiratorymuscle strength,decreased gas exchange,anddecreasedlungvolumeandcapacity(mainly ERV and FRC) due to fat deposition on the thorax and abdomen.17 Thus, when undergoing a surgical procedure, theyareexposedtohigherrisksofcomplications.

InthestudybyBlouwetal.,18 anincreasedpercentage ofrespiratoryfailurewasfoundinpatientswithBMIabove 43kgm−2afterbariatricsurgery.Similarworkshighlightthe

need for prophylactic interventions, in order to prevent respiratory complications in patients undergoing bariatric surgery.

Regarding postoperativepulmonary complications, it is knownthatmanyofthemarerelatedtothetypeofsurgery, incisionsite,typeandduration ofanesthetic andsurgical procedure,whichinterfereswiththepatient’srecovery.7

Table3 Treatmenteffectsizeofbothgroupscomparedto controlgroup.

Timepoint Cohen’sd

IOgroup POgroup

Inductionofanesthesia---extubation 0.27 0.08

Endofanesthesia---extubation 0.93 0.64

MVtime 0.16 0.08

Extubation---PACUdischarge 0.50 0.06

VM,mechanicalventilation;PACU,post-anesthesiacareunit;IO, intraoperativegroup;PO, postoperativegroup. Cohen coeffi-cientoflessthan0.3isconsideredasmalleffect,of0.4---0.7 asmoderate,andhigherthan0.8aslarge.

Thesearchforphysicaltherapyresourcesthatcanhelp toreducethetimeoftrachealintubationisofgreatvalue, as prolonged duration of surgery or anesthesia may lead tomorepronouncedpulmonarycomplications.19 Asurgical timelastingmorethan210minisan independentrisk fac-tor for the onset of pulmonary complications after upper abdominalsurgeryandis alsoassociatedwithhigher mor-tality rate.7 In the present study, the mean duration of surgery was significantly lower, but they were morbidly obesepatientswhoalreadyhavepreviouspulmonary alter-ations associated with obesity and, in fact, it is very importanttorecognizeresourcesthatmayminimize post-operativecomplicationsforthesepatients.

As for duration of surgery (anesthesia induction---extubation), there was similarity between groups. In the presentstudy,thedurationofsurgeryshowednosignificant differencebetweengroupsbecauseallstudysubjects under-wentthesamesurgicalprocedure,anestheticprotocol,and mechanicalventilation,aswellassurgeryperformedbythe same team. However, even with the proposed treatment showing a weak effect, the intubation time and conse-quently the MV time were higher in the control group. Althoughasignificanteffectofthetreatmentsproposedin thisstudycannotbeshown,thestudybyRemísticoetal.13 showedshorter durationof surgeryin thegroup receiving alveolarrecruitmentwith30cmH2OPEEP.

Perhapstheresultsofthisstudyregardingintraoperative treatmentdidnotshowastrongeffectonextubationtime reductionduetothelowerPEEPvaluesused.Thisfactmay alsobecorroboratedbyastudythatevaluatedtheeffectsof thealveolarrecruitmentmaneuverinbariatricsurgeryusing intraoperative PEEPvaluesof 5,20 and30cmH2O,

show-ingbetterbloodoxygenationwithhighervaluesofarterial oxygenpressurein subjectswhounderwentthemaneuver with 30cm H2O PEEP.12 However, in Schuman20 literature

review,theuseof10cmH2OPEEPisrecommendedforthese

patients.

Asforextubationtime,consideredfromthemaintenance anesthetic drugs discontinuation topatient extubation, it was shorter in subjects ventilated with 10cm H2O PEEP,

and subsequently in subjects who usedthe positive pres-surepreoperatively.Anotherstudyevaluatedtheeffectsof analveolarrecruitmentmaneuverwithdifferentPEEP val-uesduringbariatricsurgeryandconcludedthatthesubjects usingthemaneuverwith10cmH2OPEEPnotonlyhavelower

pulmonarycomplications,butspentlesstimeinPACU.21 Thus,withtheextubationtimereduction,the intraoper-ativeuseof10cmH2OPEEP,besidesbenefitingthepatient,

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concern for hospital administration, as intensive care accountforupto25%to30%ofallhospitalresources.22

InthestudybyErlandssonetal.,23itwasdemonstrated thatobesepatientswhoareventilatedwithhigherPEEP dur-ingbariatricsurgerytendtopreventlungcollapseandhave bettergasexchangeduringsurgery.

Therefore,itisconcludedthattheintraoperativeuseof 10cm H2O PEEP and preoperative positive pressure

influ-encedtheextubationtimeofpatientsundergoingbariatric surgery.

Conflicts

of

interest

Theauthorsdeclarenoconflictsofinterest.

References

1.World Health Organization. Media centre: obesity and overweight; 2012. Available from: http://www.who. int/mediacentre/factsheets/fs311/en/

2.Yurcisin BM, Gaddor MM, Demaria EJ. Obesity and bariatric surgery.ClinChestMed.2009;30:539---53.

3.CoutinhoWF. Consenso Latino-Americano de Obesidade. Arq BrasEndocrinolMetabol.1999;43:21---67.

4.Coussa M, Proietti S, Schnyder P, et al. Prevention of atelectasis formation during the induction of general anes-thesia in morbidly obese patients. Anesth Analg. 2004;98: 1491---5.

5.SiafakasNM,MistrouskaiI,BourosD.Surgeryandtherespiratory muscles.Thorax.1999;54:458---65.

6.ChungF,MezeiG, TongD.Pre-existingmedical conditionsas predictorsofadverseeventsinday-casesurgery.BrJAnaesth. 1999;83:262---70.

7.FilardoFA,FaresinSM,FernandesALG.Validadedeumíndice prognósticopara ocorrênciade complicac¸ões pulmonares no pós-operatóriodecirurgiaabdominalalta.AMBRevAssocMed Bras.2002;48:209---16.

8.LawrenceVA, Cornell JE, Smetana GW.Strategies to reduce postoperativepulmonarycomplicationsafternoncardiothoracic surgery:systematicreviewfortheAmericanCollegeof Physi-cians.AnnInternMed.2006;144:596---608.

9.Huerta S, Deshields S, Shpiner R, et al. Safety and effi-cacyofpostoperativecontinuouspositiveairway pressureto

prevent pulmonary complications after Roux-en-Y Gastric Bypass.JGastrointestSurg.2002;6:354---8.

10.El-SolhAA,AquilinaA,PinedaL,etal.Noninvasiveventilation forpreventionofpost-extubationrespiratoryfailure inobese patients.EurRespirJ.2006;28:588---95.

11.NeliganPJ, MalhotraG, FraserM, etal. Continuouspositive airway pressureviatheboussignac systemimmediatelyafter extubationimproveslungfunctioninmorbidlyobesepatients withobstructivesleepapneaundergoinglaparoscopicbariatric surgery.Anesthesiology.2009;110:878---84.

12.SouzaAP,BuschpigelM,MathiasLAST,etal.Análisedosefeitos da manobra de recrutamento alveolar na oxigenac¸ão san-guíneaduranteprocedimentobariátrico.RevBrasAnestesiol. 2009;59:177---86.

13.Remístico PPJ, Araújo S, Figueiredo LC, et al. Impact of alveolar recruitment maneuver in the postoperative period of videolaparoscopic bariatric surgery. Rev Bras Anestesiol. 2011;61:163---8.

14.MilerMZ,HankinsonJ,BrusacoV,etal.Standardisationoflung function testing.Standardisation ofspirometry.EurRespirJ. 2005;26:319---38.

15.AldreteJA,KroulikD.Apostanestheticrecoveryscore.Anesth Analg.1970;49:924---34.

16.MetropolitanLifeFoundation.Metropolitanheightandweight tables.StatBull.1983;64:2---9.

17.SoodA.Alteredrestingandexerciserespiratoryphysiologyin obesity.ClinChestMed.2009;30:445---54.

18.BlouwEL,RudolphAD,NarrBJ,etal.Thefrequencyof respira-toryfailureinpatientswithmorbidobesityurdergoinggastric bypass.AANAJ.2003;71:45---50.

19.ChiavegatoLD,JardimJR,Faresin SM,et al.Alterac¸ões fun-cionaisrespiratóriasnacolecistectomiaporvialaparoscópica. JPneumol.2000;26:69---76.

20.SchumannR.Anaesthesiaforbariatricsurgery.BestPractRes ClinAnaesthesiol.2011;25:83---93.

21.Talab HF, Zabani IA, Abdelrahman HS, et al. Intraoperative ventilatory strategiesfor prevention of pulmonary atelecta-sisinobesepatientsundergoinglaparoscopicbariatricsurgery. AnesthAnalg.2009;109:1511---6.

22.ChalfinDB, Cohen IL,LambrinosJ.The economicsand cost-effectiveness of critical care medicine. Intensive CareMed. 1995;21:952---61.

Imagem

Table 1 shows the anthropometric characteristics of vol- vol-unteers, with no statistical difference, indicating the sample homogeneity.
Table 3 Treatment effect size of both groups compared to control group.

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