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挥发性麻醉与癌症围手术期结局相关:一项大型随机对照试验的可行性和初步研究。

Volatile anaesthesia and peri-operative outcomes related to cancer: a feasibility and pilot study for a large randomised control trial.

机构信息

Department of Anaesthesia, Peri-operative and Pain Medicine, Peter MacCallum Cancer Centre, Melbourne, Australia.

Department of Anesthesiology and Peri-operative Medicine, Division of Anesthesiology and Critical Care, University of Texas MD Anderson Cancer Center, Houston, TX, USA.

出版信息

Anaesthesia. 2021 Sep;76(9):1198-1206. doi: 10.1111/anae.15354. Epub 2021 Jan 13.

Abstract

Published data suggest that the type of general anaesthesia used during surgical resection for cancer may impact on patient long-term outcome. However, robust prospective clinical evidence is essential to guide a change in clinical practice. We explored the feasibility of conducting a randomised controlled trial to investigate the impact of total intravenous anaesthesia with propofol vs. inhalational volatile anaesthesia on postoperative outcomes of patients undergoing major cancer surgery. We undertook a randomised, double-blind feasibility and pilot study of propofol total intravenous anaesthesia or volatile-based maintenance anaesthesia during cancer resection surgery at three tertiary hospitals in Australia and the USA. Patients were randomly allocated to receive propofol total intravenous anaesthesia or volatile-based maintenance anaesthesia. Primary outcomes for this study were successful recruitment to the study and successful delivery of the assigned anaesthetic treatment as per randomisation arm. Of the 217 eligible patients approached, 146 were recruited, a recruitment rate of 67.3% (95%CI 60.6-73.5%). One hundred and forty-five patients adhered to the randomised treatment arm, 99.3% (95%CI 96.2-100%). Intra-operative patient characteristics and postoperative complications were comparable between the two intervention groups. This feasibility and pilot study supports the viability of the protocol for a large, randomised controlled trial to investigate the effect of anaesthesia technique on postoperative cancer outcomes. The volatile anaesthesia and peri-operative outcomes related to cancer (VAPOR-C) study that is planned to follow this feasibility study is an international, multicentre trial with the aim of providing evidence-based guidelines for the anaesthetic management of patients undergoing major cancer surgery.

摘要

已有数据表明,癌症手术切除过程中使用的全身麻醉类型可能会影响患者的长期预后。然而,需要有强有力的前瞻性临床证据来指导临床实践的改变。我们探讨了开展一项随机对照试验的可行性,以调查在接受重大癌症手术的患者中,使用异丙酚全凭静脉麻醉与挥发性吸入麻醉对术后结果的影响。我们在澳大利亚和美国的三家三级医院进行了一项关于异丙酚全凭静脉麻醉或挥发性维持麻醉用于癌症切除术的随机、双盲可行性和初步研究。患者被随机分配接受异丙酚全凭静脉麻醉或挥发性维持麻醉。本研究的主要结局是成功招募研究对象并按照随机分组方案成功实施分配的麻醉治疗。在 217 名符合条件的患者中,有 146 名患者被招募,招募率为 67.3%(95%可信区间 60.6-73.5%)。145 名患者坚持了随机治疗组,占 99.3%(95%可信区间 96.2-100%)。两组干预措施的术中患者特征和术后并发症无差异。这项可行性和初步研究支持该方案进行一项大型随机对照试验的可行性,以研究麻醉技术对术后癌症结果的影响。计划在这项可行性研究之后开展的挥发性麻醉和与癌症相关的围手术期结局(VAPOR-C)研究是一项国际性的多中心试验,旨在为接受重大癌症手术的患者的麻醉管理提供循证指南。

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