Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, USA
Anesthesiology, University of Michigan Health System, Ann Arbor, Michigan, USA.
BMJ Open. 2023 Apr 17;13(4):e070096. doi: 10.1136/bmjopen-2022-070096.
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.
每年有数百万患者接受全身麻醉进行手术。关于哪种技术（异丙酚全凭静脉麻醉（TIVA）或吸入挥发性麻醉（INVA））能提供更好的患者体验、安全性和结果，证据存在关键差距。本研究旨在评估进行大型比较有效性试验评估接受异丙酚 TIVA 或 INVA 后患者体验和结果的可行性。
本方案由包括具有 TIVA 或 INVA 个人经验的患者合作伙伴在内的多元化团队共同创建。该设计是一项 300 例患者、两中心、随机、可行性试验。年龄在 18 岁或以上、需要全身麻醉和气管内导管或喉罩气道的择期非心脏手术患者将有资格参加。患者将按照中心和手术复杂性进行 1:1 随机分组至异丙酚 TIVA 或 INVA。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；（4）数据管理程序的可行性。将计算比例和 95%置信区间，以评估预定的可行性参数是否符合标准。如果接近的患者中同意参与的患者比例和每个随机治疗组的治疗分配依从性的 95%置信区间下限均高于 10%和 80%的阈值，则表明我们计划的实用 12500 例患者比较有效性试验很可能成功进行。还将描述其他可行性结果和不良事件。
本研究已获得华盛顿大学伦理委员会的批准（IRB#202205053），作为两个参与站点的单一机构审查委员会。招募于 2022 年 9 月开始。传播计划包括在科学会议上的演讲、科学出版物、互联网教育材料和大众媒体。
NCT05346588。
