Feasibility pilot trial for the Trajectories of Recovery after Intravenous propofol versus inhaled VolatilE anesthesia (THRIVE) pragmatic randomised controlled trial.
Feasibility pilot trial for the Trajectories of Recovery after Intravenous propofol versus inhaled VolatilE anesthesia (THRIVE) pragmatic randomised controlled trial.
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DOI：
10.1136/bmjopen-2022-070096
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发表时间：
2023-04-17
期刊：
影响因子：
2.9
通讯作者：
Kheterpal, Sachin
中科院分区：
文献类型：
--
作者：
Tellor Pennington, Bethany R.;Colquhoun, Douglas A.;Neuman, Mark D.;Politi, Mary C.;Janda, Allison M.;Spino, Cathie;Thelen-Perry, Steven;Wu, Zhenke;Kumar, Sathish S.;Gregory, Stephen H.;Avidan, Michael S.;Kheterpal, Sachin
每年有数百万病人接受全身麻醉手术。关于丙泊酚全静脉麻醉（TIVA）或吸入挥发性麻醉（INVA）哪种技术能产生上级的患者体验、安全性和结局，存在关键的证据差距。本初步研究的目的是评估进行一项大型比较有效性试验的可行性，该试验评估接受丙泊酚TIVA或INVA后的患者体验和结局。该方案由不同的团队共同创建，包括具有TIVA或INVA个人经验的患者合作伙伴。该设计是一项300例患者、双中心、随机、可行性初步试验。18岁或以上的患者，接受择期非心脏手术，需要使用气管插管或喉罩气道进行全身麻醉，将符合条件。患者将按1：1的比例随机分配至丙泊酚TIVA或INVA组，按中心和手术复杂性分层。可行性终点包括：（1）同意参与的患者比例;（2）接受分配的随机治疗的患者比例;（3）结局数据收集的完整性和（4）数据管理程序的可行性。将计算比例和95% CI，以评估可行性参数是否符合预先规定的阈值。如果95% CI的下限高于阈值10%（所接触的患者中同意参与的患者比例）和80%（每个随机治疗组治疗分配依从性），这将表明我们计划的务实的12500例患者比较有效性试验可能会成功进行。将描述其他可行性结果和不良事件。本研究由华盛顿大学伦理委员会（IRB# 202205053）批准，该伦理委员会作为两个参与研究中心的单一机构审查委员会。招聘工作于2022年9月开始。传播计划包括在科学会议上的介绍、科学出版物、基于互联网的教育材料和大众媒体。 NCT 05346588。
Millions of patients receive general anaesthesia for surgery annually. Crucial gaps in evidence exist regarding which technique, propofol total intravenous anaesthesia (TIVA) or inhaled volatile anaesthesia (INVA), yields superior patient experience, safety and outcomes. The aim of this pilot study is to assess the feasibility of conducting a large comparative effectiveness trial assessing patient experiences and outcomes after receiving propofol TIVA or INVA. This protocol was cocreated by a diverse team, including patient partners with personal experience of TIVA or INVA. The design is a 300-patient, two-centre, randomised, feasibility pilot trial. Patients 18 years of age or older, undergoing elective non-cardiac surgery requiring general anaesthesia with a tracheal tube or laryngeal mask airway will be eligible. Patients will be randomised 1:1 to propofol TIVA or INVA, stratified by centre and procedural complexity. The feasibility endpoints include: (1) proportion of patients approached who agree to participate; (2) proportion of patients who receive their assigned randomised treatment; (3) completeness of outcomes data collection and (4) feasibility of data management procedures. Proportions and 95% CIs will be calculated to assess whether prespecified thresholds are met for the feasibility parameters. If the lower bounds of the 95% CI are above the thresholds of 10% for the proportion of patients agreeing to participate among those approached and 80% for compliance with treatment allocation for each randomised treatment group, this will suggest that our planned pragmatic 12 500-patient comparative effectiveness trial can likely be conducted successfully. Other feasibility outcomes and adverse events will be described. This study is approved by the ethics board at Washington University (IRB# 202205053), serving as the single Institutional Review Board for both participating sites. Recruitment began in September 2022. Dissemination plans include presentations at scientific conferences, scientific publications, internet-based educational materials and mass media. NCT05346588.
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