Department of Anesthesiology and Intensive Care Medicine, University Hospital of Besancon, University of Franche-Comte, Besancon, France -
Minerva Anestesiol. 2016 Nov;82(11):1138-1148. Epub 2016 Aug 31.
The ENDOTANIL Trial aimed at comparing an association of target-controlled infusion (TCI) of remifentanil and propofol to TCI of propofol alone on the clinical conditions during pan endoscopy for assessment of the upper airway (pan endoscopy) performed under tubeless general anesthesia.
This double-blind, single center, parallel, randomized, placebo-controlled trial was conducted in a French tertiary level of care, from June 2009 to February 2013. Patients scheduled for elective pan endoscopy were anesthetized using propofol TCI combined to either remifentanil TCI (effect-site concentration=1.5 ng.mL-1; remifentanil group) or placebo (control group). The main outcome measure was the percentage of clinically acceptable conditions for pan endoscopy, using a 5-criteria score (ease of laryngoscopy, position and movements of the vocal cords, cough and movements of the limbs to stimulation). The secondary outcomes were hemodynamic and respiratory safety.
In this study 218 patients (mean±SD age 60 [10] yrs) were included. Clinically acceptable conditions were observed in 68% and 64% of the patients included in Remifentanil and Control group, respectively (P=0.39). None of the 5 parameters of the pan endoscopy score was significantly different between the 2 groups. Hemodynamic alterations were significantly lower in the Remifentanil as compared to the control group. Incidence of hypoxemia or need for rescue mechanical ventilation did not significantly differ between the 2 groups.
The adjunction of remifentanil to propofol TCI, at a dose that maintain spontaneous breathing, did not improve the conditions for pan endoscopy, but attenuates the hemodynamic response induced by upper airway stimulation.
ENDOTANIL 试验旨在比较靶控输注（TCI）瑞芬太尼和丙泊酚与单独 TCI 丙泊酚对无管全身麻醉下进行的上呼吸道全面内镜检查（pan endoscopy）期间临床状况的影响。
这是一项在法国三级护理中心进行的双盲、单中心、平行、随机、安慰剂对照试验。在 2009 年 6 月至 2013 年 2 月期间，计划接受择期 pan endoscopy 的患者使用丙泊酚 TCI 联合瑞芬太尼 TCI（效应部位浓度=1.5ng/ml；瑞芬太尼组）或安慰剂（对照组）进行麻醉。主要观察指标是使用 5 项标准评分（喉镜检查的难易程度、声带的位置和运动、咳嗽和肢体刺激运动）评估 pan endoscopy 临床可接受程度的百分比。次要结局是血流动力学和呼吸安全性。
这项研究共纳入了 218 例患者（平均年龄 60[10]岁）。瑞芬太尼组和对照组分别有 68%和 64%的患者临床状况可接受（P=0.39）。pan endoscopy 评分的 5 个参数在两组之间均无显著差异。与对照组相比，瑞芬太尼组的血流动力学变化明显较低。两组患者低氧血症的发生率或需要机械通气支持的发生率均无显著差异。
在维持自主呼吸的剂量下，瑞芬太尼与丙泊酚 TCI 联合应用并未改善 pan endoscopy 的条件，但可减轻上呼吸道刺激引起的血流动力学反应。
