Effects of Neuraxial Blockade May Be Difficult To Study Using Large Randomized Controlled Trials The PeriOperative Epidural Trial (POET) Pilot Study 英文参考文献.docVIP

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Effects of Neuraxial Blockade May Be Difficult To Study Using Large Randomized Controlled Trials The PeriOperative Epidural Trial (POET) Pilot Study 英文参考文献.doc

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Effects of Neuraxial Blockade May Be Difficult To Study Using Large Randomized Controlled Trials The PeriOperative Epidural Trial (POET) Pilot Study 英文参考文献

EffectsofNeuraxialBlockadeMayBeDifficultToStudy UsingLargeRandomizedControlledTrials:The PeriOperativeEpiduralTrial(POET)PilotStudy PeterT.Choi1*,W.ScottBeattie2,GregoryL.Bryson3,JamesE.Paul4,HomerYang3 1Department of Anesthesiology, Pharmacologyand Therapeutics, University of British Columbia, Vancouver, British Columbia,Canada, 2Department of Anaesthesia, University Health Network, Toronto, Ontario, Canada, 3Department of Anesthesiology, University of Ottawa, Ottawa, Ontario, Canada, 4Department of Anesthesia, McMasterUniversity,Hamilton,Ontario,Canada Abstract Background: Early randomized controlled trials have suggested that neuraxial blockade may reduce cardiorespiratory complicationsafternon-cardiothoracicsurgery,butrecentlargertrialshavebeeninconclusive.Weconductedapilotstudy toassessthefeasibilityofconductingalargemulticentrerandomizedcontrolledtrialinCanada. Methodology/PrincipalFindings:AfterResearchEthicsBoardapprovalsfromtheparticipatinginstitutions,subjectswere recruited if they were $45 years old, had an expected hospital stay $48hours, were undergoing a noncardiothoracic procedure amenable to epidural analgesia, met one of six risk criteria, and did not have contraindications to neuraxial blockade.Afterinformedconsent,subjectswererandomlyallocatedtocombinedepiduralanalgesia(epiduralgroup)and neuraxialanesthesia,withorwithoutgeneralanesthesia,orintravenousopioidanalgesia(IVgroup)andgeneralanesthesia. The primary outcomes were the rate of recruitment and the percents of eligible patients recruited, crossed over, and followedcompletely.Feasibilitytargetsweredefinedapriori.Ablinded,independentcommitteeadjudicatedthesecondary clinicaloutcomes.Subjectswerefolloweddailywhileinhospitalandthenat30daysaftersurgery.Analysiswasintention- to-treat. Over a15-month period, therecruitment rate was0.560.3 (mean6SEM) subjectsper weekper centre; 112/494 (22.7%)eligiblesubjectswererecruitedatfourtertiary-careteachinghospitalsinCanada.Thirteen(26.5%)of49subjectsin theep