"Sevoflurane Multiple Wash In/Wash Out at the End of Anesthesia to Reduce Agitation: a multicenter double-blind randomized controlled trial"

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

Contemporary Clinical Trials Communications(2024)

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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 minutes. 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.
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Key words
postoperative agitation,Wash In/Wash Out procedure,non-cardiac surgery,anesthesia,randomized controlled trial
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