一个随机对照试验比较几种不同的方法来预防择期剖宫产脊麻后低血压的效果.docx

一个随机对照试验比较几种不同的方法来预防择期剖宫产脊麻后低血压的效果.docx

《一个随机对照试验比较几种不同的方法来预防择期剖宫产脊麻后低血压的效果.docx》由会员分享，可在线阅读，更多相关《一个随机对照试验比较几种不同的方法来预防择期剖宫产脊麻后低血压的效果.docx（12页珍藏版）》请在冰豆网上搜索。

一个随机对照试验比较几种不同的方法来预防择期剖宫产脊麻后低血压的效果

JResMedSci. 2011September; 16（9）:

1129–1138.

PMCID:

 PMC3430037

Arandomizedcomparativetrialofcombinationalmethodsforpreventingpost-spinalhypotensionatelectivecesareandelivery*

MitraJabalameli,1 HassanAliSoltani,2 JalalHashemi,2 ShekoofeBehdad,3 and BahramSoleimani4

Authorinformation ► Articlenotes ► CopyrightandLicenseinformation ►

Goto:

Abstract

BACKGROUND:

Variousmethodshavebeenappliedtopreventmaternalhypotensionafterspinalanesthesiaforcesareandelivery.Wecomparedtheefficacyofthreecombinationalmethodsinthisregardinthecurrentstudy.

METHODS:

Inthisrandomizedcomparativetrial,150candidatesofelectivecesareandeliveryunderspinalanesthesiawereassignedtothreegroups:

crystalloidpreloadandlegbandage,colloidpreloadandlegbandage,andephedrineandlegbandage.Maternalhemodynamicchangesduring60minutesafterspinalinjectionandneonatalconditionwerecomparedamongthegroups.

RESULTS:

Thecumulativeincidenceofhypotensionwas54%,64%,and36%ingroups1to3,respectively（p=0.018）.Spinalinjectiontohypotensionintervalwassimilaramongthegroups（p=0.828）.Heartrateingroup3wassignificantlyloweratthemosttimemeasuresafteranesthesiacomparedwiththeothertwogroups（p<0.05to<0.001）.Regardingneonataloutcomes,theintervalbetweenthebirthandthefirstbreathwaslongerandtheApgarscoreatminute1wasloweringroup3comparedwiththeothergroups（p<0.001and0.038,respectively）butitwasnotclinicallyimportant.UmbilicalcordbloodpHwassimilaramongthethreegroups（p=0.248）.

CONCLUSIONS:

Amongthethreestudiedmethods,administrationofephedrineplusbandageofthelowerextremitieswasthemosteffectiveoneinreducingtheincidenceofpost-spinalhypotension.Thegroupswerenotclinicallydifferentconcerningtheeffectoftreatmentonnewbornhealth.

KEYWORDS:

 Hypotension,SpinalAnesthesia,Prophylaxis,CesareanDelivery,ApgarScore

Hypotensionisthemostcommoncomplicationfollowingspinalanesthesiaforcesareandelivery.1 Inseverecases,itcanhavedetrimentaleffectsonbothmother（unconsciousnessandpulmonaryaspiration）andneonate（hypoxia,acidosis,andneurologicalinjury）.2,3 Variouspreventivemethodsarecurrentlyusedtopreventorminimizehypotensionincludingleftuterinedisplacement,prophylacticephedrine,crystalloidorcolloidpreloading,andutilizingcompressionstockingontothelowerextremities.3 Administrationoffluidsbeforetheadministrationofregionalanesthesiacanmaintainadequatevolumeaftertheonsetofsympatheticblockade.Administrationofalargebolusofcrystalloidmayexacerbatethedecreaseincolloidosmoticpressurethatoccursduringthefirst6-12hourspostpartum.4 Also,itredistributestootherbodycompartments.Somephysiciansprefertogiveasyntheticcolloidforthispurpose.However,thesolutionsareexpensiveandmayalterbloodrheologyandplateletfunction,whichmayresultinincreasedbloodlose.Legwrappingpreventspoolingofamajorportionofthebloodvolumeinthelowerextremities,buttheincidenceofhypotensionwasreducedonlyafewpercentbythismethod.4 However,accordingtosystematicreviewsandmeta-analyses,nosinglemethodcouldeffectivelyeliminatehypotension.3,5 Intheirsystematicreview,Morganetal.introducedcolloidpreloadingandlegwrappingasthemosteffectivemethods5 whereasEmmettetal.demonstratedthattheprophylacticadministrationofcrystalloidorcolloidsolutions,ephedrine,orlegwrappingcouldnotreliablypreventhypotension.3 Accordingtoameta-analysisbyLeeetal.,theefficacyofprophylacticephedrineforthepreventionofhypotensionispooratsmallerdoses,whereasatlargerdoses,thelikelihoodofcausinghypertensionismorethanthatofpreventinghypotensionwithaminordecreaseinumbilicalarterialpH,aswell.Theauthors,therefore,didnotrecommendtheroutineadministrationofprophylacticephedrineinthisregard.6

Thedegreeofeffectivenessofvariouspreventivemethodsiscontroversial.Thereisnoestablishedidealtechnique,andthereisalackofstudiesonneonataloutcome.Systematicreviewsrecommendedfutureresearchestobedirectedtowardassessingacombinationofthebeneficialinterventions,butfewreportsareavailableontheefficacyofcombinationalmethods7–10 andmorestudiesareneededinthisregard.Thepresentstudywasperformedtocomparetheefficacyofthreecombinationalmethodsonpreventionofhypotensionfollowingspinalanesthesiainparturientsundergoingelectivecesareandelivery.Furthermore,thisstudyevaluatedtheeffectofthesemethodsonneonataloutcome.Thethreecombinationalmethodsofthestudywereasfollows:

crystalloidpreloadpluslegbandage,colloidpreloadpluslegbandageandprophylacticephedrinepluslegbandage.

Goto:

Methods

Thisrandomized,doubleblindclinicaltrialwasconductedintwouniversityhospitals（BeheshtiandShahidSadoughi,inIsfahanandYazdcities,respectively,Iran）fromsummer2005tospring2009.AfterobtainingapprovalfromtheEthicsCommitteeofIsfahanUniversityofMedicalSciences,werecruitedsingletonparturientswithAmericanSocietyofAnesthesiologists（ASA）physicalstatusIorIIwhowerescheduledforelectivecesareandeliveryunderspinalanesthesia.Writteninformedconsentwasobtainedfromallparturientsafterfullexplanationsofthegoalsandproceduresofthestudy.Parturientswithoutpreexistingsystemicdiseaseorpregnancy-inducedhypertension,pretermlabororsignsofonsetoflabor,knownfetalabnormalities,orwithoutcontraindicationstospinalanesthesiawereincludedinthestudy.Exclusioncriteriawereanysignificanthistoryofmaternalmedicalorobstetricillnessandanyfetalcompromisewithinthecurrentpregnancy.Thepatientandallstaffinvolvedinthestudywereblindtotheprotocolused.Poweranalysisshowedthatasamplesizeof50parturientspergroupwouldhave80%poweratthe5%significanceleveltodetectadifferenceof30%intheincidenceofhypotensionamongthegroups.Thesamplingmethodwasconsecutiveandeligibleparturientswererandomizedintothefollowingthreegroupsusingcomputergeneratedtableofrandomnumbers:

11

Group1:

Ringer'slactate（RL）solution（15ml/kg）wasinfusedin30minutesbeforespinalinjection.Also,midthigh-highlowerextremitiesbandage（Cobelco,Iran）wasperformedimmediatelyafterspinalinjection.

Group2:

Priortospinalinjection,colloidsolution（Hemaxel,7mg/kg）wasinfusedin30minutesandmidthigh-highlowerextremitiesbandagewasperformedimmediatelyafterspinalinjection.

Group3:

Immediatelyafterspinalinjection,ephedrine（15mg,IV,bolus）wasinfusedin45secondsandalsomidthigh-highbandageoflowerextremitieswasdone.

SpinalanesthesiawasperformedinallcasesinsittingpositioninL3-L4orL4-L5spaces.TheanesthesiawasdonewithplainMarcaine（0.5%,2.7ml）（CurasanCo.,Iran）anddextrosesolution（50%,0.3ml）usingspinalneedle25-gauge（pencilpoint,Braun,Melsungen,Germany）.Then,theparturientwassettotheleftlateralpositionandafterestablishmentofT4blockwithpinpricktestandconfirmationofanesthesia,cesareansectionwasdone.Oxytocin（20IUin1000mlRLsolution）wasinfusedduringonehourafterdeliveryinordertoretainthenormaluteraltone.Eachparturientreceived10ml/kgRLsolutionduringanesthesia.

Fromenteringintotheoperatingroomtodischargingfromtherecoveryroom,allcasesweremonitoredbynon-invasivebloodpressuremonitoring,pulseoximetry,electrocardiography,andbleedingandurinevolumes.Ifhypotensionoccurred,asdefinedbysystolicbloodpressure（SBP）below90mmHgorgreaterthan20%belowbaselinemeasures,rescuebolusesofephedrine（5mg）weregiveneachfiveminutesuntilhypotensionresolved.Theseverityofnausea,asreportedbyparturient,wasassessedbyanursewhowasblindtothestudyonoperationbedandalsoinrecoveryroomby100mmVisualAnalogScale（VAS）anddefinedassevereifexceeded40mm.Incaseofvomitingorseverenausea,duringoperationatropine（0.5mg,IV）andinrecoveryroommetoclopramide（10mg,IV）wereadministered.SBP,diastolicbloodpressure（DBP）,andheartrate（HR）ofparturientswererecordedattheadmissiontooperatingroom（baseline）,immediatelyafteranesthesia（displayedastime0）,andminutes3,5,15,20,25,30,35,and60afterspinalinjection.Timeintervalbetweenthespinalinjectionandoccurrenceofhypotension,prolongationofhypotension（timethatsystolicbloodpressurewaslessthan20percentofbaselinebloodpressure）,andtheamountofrescueephedrineadministeredwererecorded.Followingthedelivery,theintervalbetweenneonatalbirthandfirstbreathafterdelivery,Apgarscoresatmin1and5,umbilicalcordbloodpH（fromumbilicalarteryisolatedbyproximalanddistalclampinasyringewashedwithsolutionincluded1000unitheparinpermilliliter）,andneurologicandadaptivecapacityscore（NACS）at15minutes,2hours,and24hoursafterdeliveryweredeterminedbyaphysicianwhowasblindtotheprocedure.

Theprimaryoutcomeofthestudywasdefinedastheincidenceofhypotension.SecondaryoutcomesincludedchangesinbloodpressureandHR,theincidenceofbradycardia（HR<50bpm）,hypertension（SBP>140mmHgor>20%ofthebaselinevalues）,spinalinjectiontohypotensioninterval,theprolongationofhypotension,amountofrescueephedrineadministered,nausea,vomiting,theintervalbetweenbirthandfirstneonatalbreathafterdelivery,umbilicalcordpH,Apgarscoresatmin1and5,andNACS.TheincidenceandtimingofhypotensionwereanalyzedusingKaplan-Meier