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
{"title":"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","authors":"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","doi":"10.1016/j.conctc.2024.101316","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Discussion</h3><p>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.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.4000,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000632/pdfft?md5=e6edf3c960e2f8f6c8502ee65605d40e&pid=1-s2.0-S2451865424000632-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Sevoflurane multiple Wash In/Wash Out at the end of anesthesia to reduce agitation: A multicenter double-blind randomized controlled trial\",\"authors\":\"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\",\"doi\":\"10.1016/j.conctc.2024.101316\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Discussion</h3><p>The OPERA trial investigates the effect of the Wash In/Wash Out procedure to reduce post-anesthetic agitation in non-cardiac surgery. 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Sevoflurane multiple Wash In/Wash Out at the end of anesthesia to reduce agitation: A multicenter double-blind randomized controlled trial
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.
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.
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