Devroe Sarah, Devriese Lisa, Debuck Frederik, Fieuws Steffen, Cools Bjorn, Gewillig Marc, Van de Velde Marc, Rex Steffen
Department of Anesthesiology, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium.
Department of Pediatric and Congenital Cardiology, University Hospitals Leuven, Leuven, Belgium.
Trials. 2020 Apr 3;21(1):310. doi: 10.1186/s13063-020-4231-5.
Emergence delirium, a manifestation of acute postoperative brain dysfunction, is frequently observed after pediatric anesthesia and has been associated with the use of sevoflurane. Both xenon and dexmedetomidine possess numerous desirable properties for the anesthesia of children with congenital heart disease, including hemodynamic stability, lack of neurotoxicity, and a reduced incidence of emergence delirium. Combining both drugs has never been studied as a balanced-anesthesia technique. This combination allows the provision of anesthesia without administering anesthetic drugs against which the Food and Drug Administration (FDA) issued a warning for the use in young children.
METHODS/DESIGN: In this phase-II, mono-center, prospective, single-blinded, randomized, controlled pilot trial, we will include a total of 80 children aged 0-3 years suffering from congenital heart disease and undergoing general anesthesia for elective diagnostic and/or interventional cardiac catheterization. Patients are randomized into two study groups, receiving either a combination of xenon and dexmedetomidine or mono-anesthesia with sevoflurane for the maintenance of anesthesia. The purpose of this study is to estimate the effect size for xenon-dexmedetomidine versus sevoflurane anesthesia with respect to the incidence of emergence delirium in children. We will also describe group differences for a variety of secondary outcome parameters including peri-interventional hemodynamics, emergence characteristics, incidence of postoperative vomiting, and the feasibility of a combined xenon-dexmedetomidine anesthesia in children.
Sevoflurane is the most frequently used anesthetic in young children, but has been indicated as an independent risk factor in the development of emergence delirium. Xenon and dexmedetomidine have both been associated with a reduction in the incidence of emergence delirium. Combining xenon and dexmedetomidine has never been described as a balanced-anesthesia technique in children. Our pilot study will therefore deliver important data required for future prospective clinical trials.
EudraCT, 2018-002258-56. Registered on 20 August 2018. https://www.clinicaltrialsregister.eu.
苏醒期谵妄是小儿麻醉后急性脑功能障碍的一种表现，在小儿麻醉后经常出现，且与七氟烷的使用有关。氙气和右美托咪定对先天性心脏病患儿麻醉具有许多理想的特性，包括血流动力学稳定、无神经毒性以及降低苏醒期谵妄的发生率。将这两种药物联合使用作为一种平衡麻醉技术从未被研究过。这种联合使用允许在不使用美国食品药品监督管理局（FDA）针对幼儿使用发出警告的麻醉药物的情况下提供麻醉。
方法/设计：在这项II期、单中心、前瞻性、单盲、随机、对照试验中，我们将纳入总共80名年龄在0至3岁患有先天性心脏病且因择期诊断性和/或介入性心导管检查而接受全身麻醉的儿童。患者被随机分为两个研究组，分别接受氙气和右美托咪定联合使用或七氟烷单药麻醉以维持麻醉。本研究的目的是估计氙气-右美托咪定与七氟烷麻醉相比对儿童苏醒期谵妄发生率的效应大小。我们还将描述各种次要结局参数的组间差异，包括介入期间的血流动力学、苏醒特征、术后呕吐发生率以及氙气-右美托咪定联合麻醉在儿童中的可行性。
七氟烷是幼儿最常用的麻醉剂，但已被指出是苏醒期谵妄发生的独立危险因素。氙气和右美托咪定都与苏醒期谵妄发生率的降低有关。将氙气和右美托咪定联合使用作为儿童平衡麻醉技术从未被描述过。因此，我们的初步研究将提供未来前瞻性临床试验所需的重要数据。
EudraCT，2018 - 002258 - 56。于2018年8月20日注册。https://www.clinicaltrialsregister.eu。
