Tellor Pennington Bethany R, Janda Allison M, Colquhoun Douglas A, Neuman Mark D, Kidwell Kelley M, Spino Cathie, Thelen-Perry Steven, Krambrink Amy, Huang Suiyuan, Ignacio Rose, Wu Zhenke, Swisher Laura, Cloyd Chelsea, Vaughn Michelle T, Pescatore Nicole A, Bollini Mara L, Mashour George A, Hassett Afton, Kent Christopher D, Vlisides Phillip E, Avidan Michael S, Kheterpal Sachin
Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, USA
Department of Anesthesiology, University of Michigan Health System, Ann Arbor, Michigan, USA.
BMJ Open. 2025 Sep 14;15(9):e103836. doi: 10.1136/bmjopen-2025-103836.
Millions of patients receive general anaesthesia every year with either propofol total intravenous anaesthesia (TIVA) or inhaled volatile anaesthesia (INVA). It is currently unknown which of these techniques is superior in relation to patient experience, safety and clinical outcomes. The primary aims of this trial are to determine (1) whether patients undergoing (a) major inpatient surgery, (b) minor inpatient surgery or (c) outpatient surgery have a superior quality of recovery after INVA or TIVA and (2) whether TIVA confers no more than a small (0.2%) increased risk of definite intraoperative awareness than INVA.
This protocol was co-created by a diverse team, including patient partners with personal experience of TIVA or INVA. The design is a 13 000-patient, multicentre, patient-blinded, randomised, comparative effectiveness 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 one of two anaesthetic approaches, TIVA or INVA, using minimisation. The primary effectiveness endpoints are Quality of Recovery-15 (QOR-15) score on postoperative day (POD) 1 in patients undergoing (1) major inpatient surgery, (2) minor inpatient surgery or (3) outpatient surgery, and the primary safety endpoint is the incidence of unintended definite intraoperative awareness with recall in all patients, assessed on POD1 or POD30. Secondary endpoints include QOR-15 score on POD0, POD2 and POD7; incidence of delirium on POD0 and POD1; functional status on POD30 and POD90; health-related quality of life on POD30, POD90, POD180 and POD365; days alive and at home at POD30; patient satisfaction with anaesthesia at POD2; respiratory failure on POD0; kidney injury on POD7; all-cause mortality at POD30 and POD90; intraoperative hypotension; moderate-to-severe intraoperative movement; unplanned hospital admission after outpatient surgery in a free-standing ambulatory surgery centre setting; propofol-related infusion syndrome and malignant hyperthermia.
This study is approved by the ethics board at Washington University, serving as the single Institutional Review Board for all participating sites. Recruitment began in September 2023. Dissemination plans include presentations at scientific conferences, scientific publications, internet-based educational materials and mass media.
NCT05991453.
每年有数百万患者接受全身麻醉，采用丙泊酚全静脉麻醉（TIVA）或吸入挥发性麻醉（INVA）。目前尚不清楚这两种技术在患者体验、安全性和临床结局方面哪种更具优势。本试验的主要目的是确定：（1）接受（a）大型住院手术、（b）小型住院手术或（c）门诊手术的患者在接受INVA或TIVA后是否具有更好的恢复质量；（2）与INVA相比，TIVA导致明确术中知晓的风险增加是否不超过小幅度（0.2%）。
本方案由一个多元化团队共同制定，包括有TIVA或INVA个人经历的患者代表。该设计为一项纳入13000名患者的多中心、患者盲法、随机、比较有效性试验。年龄在18岁及以上、接受需要气管插管或喉罩气道全身麻醉的择期非心脏手术的患者符合条件。患者将使用最小化法以1:1随机分配至两种麻醉方法之一，即TIVA或INVA。主要有效性终点为接受（1）大型住院手术、（2）小型住院手术或（3）门诊手术的患者术后第1天的恢复质量-15（QOR-15）评分，主要安全性终点为所有患者在术后第1天或第30天评估的意外明确术中知晓并伴有回忆的发生率。次要终点包括术后第0天、第2天和第7天的QOR-15评分；术后第0天和第1天的谵妄发生率；术后第30天和第90天的功能状态；术后第30天、第90天、第180天和第365天的健康相关生活质量；术后第30天存活且在家的天数；术后第2天患者对麻醉的满意度；术后第0天的呼吸衰竭；术后第7天的肾损伤；术后第30天和第90天的全因死亡率；术中低血压；中度至重度术中体动；在独立门诊手术中心环境下门诊手术后的非计划住院；丙泊酚相关输注综合征和恶性高热。
本研究已获得华盛顿大学伦理委员会批准，该委员会作为所有参与站点的单一机构审查委员会。招募工作于2023年9月开始。传播计划包括在科学会议上发表演讲、科学出版物、基于互联网的教育材料和大众媒体。
NCT05991453。
