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可弯曲支气管镜检查中靶控输注与分次给予丙泊酚镇静的随机非劣效性试验

Target-controlled versus fractionated propofol sedation in flexible bronchoscopy: A randomized noninferiority trial.

作者信息

Franzen Daniel, Bratton Daniel J, Clarenbach Christian F, Freitag Lutz, Kohler Malcolm

机构信息

Department of Pulmonology, University Hospital Zurich, Zurich, Switzerland.

出版信息

Respirology. 2016 Nov;21(8):1445-1451. doi: 10.1111/resp.12830. Epub 2016 Jun 15.

DOI:10.1111/resp.12830
PMID:27302000
Abstract

BACKGROUND AND OBJECTIVE

Fractionated propofol administration (FPA) in flexible bronchoscopy (FB) may lead to oversedation and an increased risk of adverse events, because a stable plasma concentration of propofol is not maintainable. The purpose of this randomized noninferiority trial was to evaluate whether target-controlled infusion (TCI) of propofol is noninferior to FPA in terms of safety in FB.

METHODS

Coprimary outcomes were the mean lowest arterial oxygen saturation (SpO ) during FB and the number of propofol dose adjustments in relation to procedure duration. Secondary outcomes were the number of occasions with SpO  < 90% and/or oxygen desaturations of >4% from baseline, number of occasions with systolic blood pressure < 90 mm Hg, cough frequency, cumulative propofol dose, recovery time, maximum transcutaneous CO , mean SpO and O delivery during FB.

RESULTS

Seventy-seven patients were included. TCI was noninferior to FPA in terms of mean (standard deviation) lowest SpO during the procedure (88.3% (5.4%) vs 86.9% (7.3%)) and required fewer dose adjustments (0.04/min vs 0.28/min, P < 0.001) but a higher cumulative propofol dose (264 vs 194 mg, P = 0.003). All other secondary outcomes were comparable between the groups.

CONCLUSION

We suggest that TCI of propofol is a favourable sedation technique for FB with equal safety issues and fewer dose adjustments compared with FPA.

摘要

背景与目的

在可弯曲支气管镜检查(FB)中,分次给予丙泊酚(FPA)可能会导致镇静过度以及不良事件风险增加,因为丙泊酚的血浆浓度无法维持稳定。这项随机非劣效性试验的目的是评估在FB中丙泊酚靶控输注(TCI)在安全性方面是否不劣于FPA。

方法

共同主要结局为FB期间的平均最低动脉血氧饱和度(SpO)以及与操作持续时间相关的丙泊酚剂量调整次数。次要结局包括SpO<90%和/或血氧饱和度较基线下降>4%的次数、收缩压<90 mmHg的次数、咳嗽频率、丙泊酚累积剂量、恢复时间、最大经皮二氧化碳分压、FB期间的平均SpO和氧输送量。

结果

纳入77例患者。在操作期间,TCI在平均(标准差)最低SpO方面不劣于FPA(88.3%(5.4%)对86.9%(7.3%)),且所需剂量调整较少(0.04/分钟对0.28/分钟,P<0.001),但丙泊酚累积剂量较高(264对194 mg,P = 0.003)。两组之间所有其他次要结局相当。

结论

我们认为,丙泊酚TCI是一种适用于FB的镇静技术,与FPA相比,安全性问题相当且剂量调整较少。

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