Sevoflurane multiple Wash In/Wash Out at the end of anesthesia to reduce agitation: A multicenter double-blind randomized controlled trial

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2024-06-01 DOI:10.1016/j.conctc.2024.101316

Giovanni Landoni , Valery V. Likhvantsev , Levan B. Berikashvili , Andrey G. Yavorovsky , Pavel S. Bagdasarov , Anastasia V. Smirnova , Tatiana S. Serkova , Valery V. Subbotin , Kristina K. Kadantseva , Alexey M. Ovezov , Mikhail Ya Yadgarov , Alexey A. Yakovlev , Andrea Lamacchia , Lorenzo Gallo , Nadezhda D. Gracheva , Pavel V. Ryzhkov , Rachele Zilocchi , Jessica De Vecchi , Maksim A. Aleinikov , Pavel S. Mayuk , Maria M. Shemetova

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引用次数: 0

Abstract

Background

Postoperative agitation is common after non-cardiac surgery. It is associated with postoperative delirium and cognitive dysfunction, leading to prolonged hospital stay and delayed social readjustment. Prevention and treatment strategies are lacking. We assessed the efficacy of a novel approach, the Wash In/Wash Out procedure, in reducing post-anesthetic agitation.

Methods

This multicenter, parallel-group, double-blind randomized controlled trial is enrolling 200 patients undergoing open abdominal surgery. Participants are randomly assigned to either a control group receiving standard recovery methods or an investigational group undergoing the Wash In/Wash Out procedure. In the Wash In/Wash Out procedure group, sevoflurane is stopped and then promptly restarted when the patient shows the first signs of awakening to achieve an end-tidal concentration of 1 minimum alveolar concentration (MAC) for 5 min. This stop-and-restart cycle is performed three times. The trial's primary outcome is the rate of postoperative agitation. Secondary outcomes include rate of postoperative delirium and cognitive dysfunction, postoperative nausea and vomiting, and length of intensive care and hospital stay.

Discussion

The OPERA trial investigates the effect of the Wash In/Wash Out procedure to reduce post-anesthetic agitation in non-cardiac surgery. This study could offer a significant contribution to improving patient outcomes and optimizing recovery protocols in surgical settings.

Abstract Image

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在麻醉结束时进行七氟醚多次 "洗入/洗出 "以减少躁动：多中心双盲随机对照试验

背景术后躁动在非心脏手术后很常见。它与术后谵妄和认知功能障碍有关，导致住院时间延长和社会重新适应延迟。目前尚缺乏预防和治疗策略。我们评估了一种新方法--"洗入/洗出 "程序--在减少麻醉后躁动方面的疗效。方法这项多中心、平行组、双盲随机对照试验正在招募 200 名接受开腹手术的患者。参与者被随机分配到接受标准恢复方法的对照组或接受洗入/洗出程序的研究组。在 "洗入/洗出 "程序组中，先停止七氟醚的使用，然后在患者出现苏醒迹象时立即重新启动七氟醚，使潮气末浓度达到 1 个最小肺泡浓度 (MAC)，持续 5 分钟。这种停止-重启循环要进行三次。试验的主要结果是术后躁动率。次要结果包括术后谵妄和认知功能障碍发生率、术后恶心和呕吐以及重症监护和住院时间。讨论 OPERA 试验调查了 "洗入/洗出 "程序对减少非心脏手术麻醉后躁动的效果。这项研究可为改善患者预后和优化手术恢复方案做出重大贡献。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.