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

Autor: Landoni G; Department of Anaesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Italy.; Vita-Salute San Raffaele University, Milan, Italy., Likhvantsev VV; Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology, Moscow, Russia.; First University Clinical Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation, Moscow, Russia., Berikashvili LB; Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology, Moscow, Russia., Yavorovsky AG; First University Clinical Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation, Moscow, Russia., Bagdasarov PS; First University Clinical Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation, Moscow, Russia., Smirnova AV; Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology, Moscow, Russia., Serkova TS; First University Clinical Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation, Moscow, Russia., Subbotin VV; A. Loginov Moscow Scientific Clinical Center, Moscow, Russia., Kadantseva KK; Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology, Moscow, Russia.; A. Loginov Moscow Scientific Clinical Center, Moscow, Russia., Ovezov AM; M. Vladimirsky Moscow Regional Research and Clinical Institute, Moscow, Russia., Yadgarov MY; Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology, Moscow, Russia., Yakovlev AA; Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology, Moscow, Russia., Lamacchia A; Department of Anaesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Italy., Gallo L; Department of Anaesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Italy., Gracheva ND; Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology, Moscow, Russia., Ryzhkov PV; Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology, Moscow, Russia., Zilocchi R; Department of Anaesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Italy., Vecchi J; Department of Anaesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Italy., Aleinikov MA; First University Clinical Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation, Moscow, Russia., Mayuk PS; First University Clinical Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation, Moscow, Russia., Pivovarova AA; M. Vladimirsky Moscow Regional Research and Clinical Institute, Moscow, Russia., Shemetova MM; Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology, Moscow, Russia.; Moscow City Oncological Hospital No.1, Moscow, Russia.
Jazyk: angličtina
Zdroj: Contemporary clinical trials communications [Contemp Clin Trials Commun] 2024 May 29; Vol. 39, pp. 101316. Date of Electronic Publication: 2024 May 29 (Print Publication: 2024).
DOI: 10.1016/j.conctc.2024.101316
Abstrakt: 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.
Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(© 2024 Published by Elsevier Inc.)
Databáze: MEDLINE