Franzen Daniel, Bratton Daniel J, Clarenbach Christian F, Freitag Lutz, Kohler Malcolm
Department of Pulmonology, University Hospital Zurich, Zurich, Switzerland.
Respirology. 2016 Nov;21(8):1445-1451. doi: 10.1111/resp.12830. Epub 2016 Jun 15.
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.
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.
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.
We suggest that TCI of propofol is a favourable sedation technique for FB with equal safety issues and fewer dose adjustments compared with FPA.
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。
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。
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。
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。