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氙气作为4岁以下接受介入性或诊断性心导管插入术儿童七氟醚麻醉的辅助剂:一项随机对照临床试验。

Xenon as an adjuvant to sevoflurane anesthesia in children younger than 4 years of age, undergoing interventional or diagnostic cardiac catheterization: A randomized controlled clinical trial.

作者信息

Devroe Sarah, Meeusen Roselien, Gewillig Marc, Cools Bjorn, Poesen Koen, Sanders Robert, Rex Steffen

机构信息

Department of Anesthesiology, University Hospitals Leuven, Leuven, Belgium.

Department of Pediatric and Congenital Cardiology, University Hospitals Leuven, Leuven, Belgium.

出版信息

Paediatr Anaesth. 2017 Dec;27(12):1210-1219. doi: 10.1111/pan.13230. Epub 2017 Sep 5.

Abstract

BACKGROUND

Xenon has repeatedly been demonstrated to have only minimal hemodynamic side effects when compared to other anesthetics. Moreover, in experimental models, xenon was found to be neuroprotective and devoid of developmental neurotoxicity. These properties could render xenon attractive for the anesthesia in neonates and infants with congenital heart disease. However, experience with xenon anesthesia in children is scarce.

AIMS

We hypothesized that in children undergoing cardiac catheterization, general anesthesia with a combination of sevoflurane with xenon results in superior hemodynamic stability, compared to sevoflurane alone.

METHODS

In this prospective, randomized, single-blinded, controlled clinical trial, children with a median age of 12 [IQR 3-36] months undergoing diagnostic/interventional cardiac catheterization were randomized to either general anesthesia with 50-65vol% xenon plus sevoflurane or sevoflurane alone. The primary outcome was the incidence of intraprocedural hemodynamic instability, defined as the occurrence of: (i) a heart rate change >20% from baseline; or (ii) a change in mean arterial blood pressure >20% from baseline; or (iii) the requirement of vasopressors, inotropes, chronotropes, or fluid boluses. Secondary endpoints included recovery characteristics, feasibility criteria, and safety (incidence of emergence agitation and postoperative vomiting.

RESULTS

After inclusion of 40 children, the trial was stopped as an a priori planned blinded interim analysis revealed that the overall rate of hemodynamic instability did not differ between groups [100% in both the xenon-sevoflurane and the sevoflurane group. However, the adjuvant administration of xenon decreased vasopressor requirements, preserved better cerebral oxygen saturation, and resulted in a faster recovery. Xenon anesthesia was feasible (with no differences in the need for rescue anesthetics in both groups).

CONCLUSION

Our observations suggest that combining xenon with sevoflurane in preschool children is safe, feasible, and facilitates hemodynamic management. Larger and adequately powered clinical trials are warranted to investigate the impact of xenon on short- and long-term outcomes in pediatric anesthesia.

摘要

背景

与其他麻醉剂相比,氙气已多次被证明仅具有极小的血流动力学副作用。此外,在实验模型中,发现氙气具有神经保护作用且无发育神经毒性。这些特性可能使氙气对患有先天性心脏病的新生儿和婴儿的麻醉具有吸引力。然而,儿童氙气麻醉的经验很少。

目的

我们假设,在接受心导管检查的儿童中,与单独使用七氟醚相比,七氟醚与氙气联合进行全身麻醉可产生更好的血流动力学稳定性。

方法

在这项前瞻性、随机、单盲、对照临床试验中,将中位年龄为12[四分位间距3 - 36]个月、接受诊断性/介入性心导管检查的儿童随机分为接受50 - 65体积%氙气加七氟醚的全身麻醉组或单独使用七氟醚组。主要结局是术中血流动力学不稳定的发生率,定义为出现以下情况:(i)心率较基线变化>20%;或(ii)平均动脉血压较基线变化>20%;或(iii)需要血管升压药、正性肌力药、变时性药物或液体冲击。次要终点包括恢复特征、可行性标准和安全性(苏醒期躁动和术后呕吐的发生率)。

结果

纳入40名儿童后,由于一项预先计划的盲法中期分析显示两组之间血流动力学不稳定的总体发生率无差异[氙气 - 七氟醚组和七氟醚组均为100%],试验停止。然而,氙气的辅助给药减少了血管升压药的需求,维持了更好的脑氧饱和度,并导致更快的恢复。氙气麻醉是可行的(两组在抢救麻醉剂需求方面无差异)。

结论

我们的观察结果表明,在学龄前儿童中将氙气与七氟醚联合使用是安全、可行的,并且有助于血流动力学管理。有必要进行更大规模且有足够效力的临床试验,以研究氙气对小儿麻醉短期和长期结局的影响。

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