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氙气与异氟烷在择期手术患者中的疗效与安全性的多中心随机对照研究

Multicenter randomized comparison of the efficacy and safety of xenon and isoflurane in patients undergoing elective surgery.

作者信息

Rossaint Rolf, Reyle-Hahn Matthias, Schulte Am Esch Jochen, Scholz Jens, Scherpereel Philippe, Vallet Benoit, Giunta Francesco, Del Turco Monica, Erdmann Wilhelm, Tenbrinck Rob, Hammerle Alfons F, Nagele Peter

机构信息

Department of Anesthesiology of the University Hospital, RWTH Aachen, Germany.

出版信息

Anesthesiology. 2003 Jan;98(1):6-13. doi: 10.1097/00000542-200301000-00005.

Abstract

BACKGROUND

All general anesthetics used are known to have a negative inotropic side effect. Since xenon does not have a negative inotropic effect, it could be an interesting future general anesthetic. The aim of this clinical multicenter trial was to test the hypothesis of whether recovery after xenon anesthesia is faster compared with an accepted, standardized anesthetic regimen and that it is as effective and safe.

METHOD

A total of 224 patients in six centers were included in the protocol. They were randomly assigned to receive either xenon (60 +/- 5%) in oxygen or isoflurane (end-tidal concentration, 0.5%) combined with nitrous oxide (60 +/- 5%). Sufentanil (10 mcirog) was intravenously injected if indicated by defined criteria. Hemodynamic, respiratory, and recovery parameters, the amount of sufentanil, and side effects were assessed.

RESULTS

The recovery parameters demonstrated a statistically significant faster recovery from xenon anesthesia when compared with isoflurane-nitrous oxide. The additional amount of sufentanil did not differ between both anesthesia regimens. Hemodynamics and respiratory parameters remained stable throughout administration of both anesthesia regimens, with advantages for the xenon group. Side effects occurred to the same extent with xenon in oxygen and isoflurane-nitrous oxide.

CONCLUSION

This first randomized controlled multicenter trial on the use of xenon as an inhalational anesthetic confirms, in a large group of patients, that xenon in oxygen provides effective and safe anesthesia, with the advantage of a more rapid recovery when compared with anesthesia using isoflurane-nitrous oxide.

摘要

背景

已知所有常用的全身麻醉药都有负性肌力副作用。由于氙气没有负性肌力作用,它可能是一种未来值得关注的全身麻醉药。这项临床多中心试验的目的是检验氙气麻醉后恢复是否比公认的标准化麻醉方案更快,以及其有效性和安全性是否相当的假设。

方法

共有来自六个中心的224例患者纳入该方案。他们被随机分配接受氧气中含氙气(60±5%)或异氟烷(呼气末浓度0.5%)联合氧化亚氮(60±5%)。根据既定标准,如有需要静脉注射舒芬太尼(10微克)。评估血流动力学、呼吸和恢复参数、舒芬太尼用量及副作用。

结果

与异氟烷-氧化亚氮相比,恢复参数显示氙气麻醉后的恢复在统计学上显著更快。两种麻醉方案中舒芬太尼的额外用量无差异。在两种麻醉方案的给药过程中,血流动力学和呼吸参数均保持稳定,氙气组有优势。氧气中氙气和异氟烷-氧化亚氮的副作用发生率相同。

结论

这项关于使用氙气作为吸入麻醉药的首次随机对照多中心试验在一大组患者中证实,氧气中氙气可提供有效且安全的麻醉,与使用异氟烷-氧化亚氮麻醉相比,具有恢复更快的优势。

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