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局部鼻用羟甲唑啉用于纤维支气管镜检查(VAIN):一项随机、双盲、安慰剂对照试验。

Topical nasal xylometazoline for flexible bronchoscopy (VAIN): A randomized, double-blind, placebo-controlled trial.

机构信息

Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi, 110029, India.

Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi, 110029, India.

出版信息

Respir Investig. 2021 May;59(3):350-355. doi: 10.1016/j.resinv.2020.12.004. Epub 2021 Jan 29.

DOI:10.1016/j.resinv.2020.12.004
PMID:33518471
Abstract

BACKGROUND

The role of topical nasal vasoconstrictor administration during flexible bronchoscopy is unclear.

METHODS

Consecutive subjects undergoing flexible bronchoscopy were randomized to receive either topical xylometazoline (0.1%) or placebo (saline nasal spray, 0.74% w/v isotonic solution) before bronchoscopy. Background topical anesthesia included 2% nasal lignocaine gel, pharyngeal spray of 10% lignocaine, and 1% lignocaine solution for spray-as-you-go administration. The primary outcome was the operator rated ease of nasal negotiation of the bronchoscope on the visual analog scale (Negotiation VAS). Secondary objectives included assistant rated facial pain scale score, patient-rated nasal pain score (Pain VAS), time to reach the vocal cords after bronchoscope insertion, operator rated nasal mucosal trauma score (Trauma VAS), hemodynamic changes, and complications between the groups.

RESULTS

In all, 148 subjects were recruited and randomized to the placebo (73) and xylometazoline groups (75). Operator rated ease of nasal bronchoscope negotiation (Negotiation VAS) was similar in both the groups [Median (IQR), 1 (1-2) in both groups, p = 0.79]. There were no differences in the other outcomes including assistant rated score of facial pain [(Median (IQR), 2 (2-4) placebo and 2 (2-4) xylometazoline, p = 0.36], Pain VAS [Median (IQR), placebo 2 (1-2) and xylometazoline 2 (1-3), p = 0.28], Trauma VAS, [Median (IQR), placebo 1 (0-2) and xylometazoline 1 (0-1), p = 0.28], hemodynamic changes, or complications between the two groups.

CONCLUSION

The findings of this study do not support the administration of topical nasal xylometazoline in flexible bronchoscopy.

TRIAL REGISTRY

Trial registered on Clinicaltrials.gov, www.clinicaltrials.govNCT03424889, on January 02, 2018.

摘要

背景

在软性支气管镜检查中,局部使用鼻血管收缩剂的作用尚不清楚。

方法

连续接受软性支气管镜检查的受试者被随机分配在支气管镜检查前接受局部使用羟甲唑啉(0.1%)或安慰剂(0.74%w/v 等渗盐水鼻喷雾剂)。背景局部麻醉包括 2%的鼻利多卡因凝胶、10%利多卡因咽部喷雾和 1%利多卡因溶液用于按需喷雾。主要结局是操作者根据视觉模拟量表(协商 VAS)评估鼻腔通过支气管镜的难易程度。次要目标包括助手评估的面部疼痛评分、患者评估的鼻腔疼痛评分(疼痛 VAS)、支气管镜插入后到达声带的时间、操作者评估的鼻黏膜创伤评分(创伤 VAS)、血流动力学变化和两组之间的并发症。

结果

共纳入 148 名受试者,并随机分为安慰剂(73 名)和羟甲唑啉组(75 名)。两组操作者评估的鼻腔支气管镜协商难易程度相似[中位数(IQR),两组均为 1(1-2),p=0.79]。其他结果无差异,包括助手评估的面部疼痛评分[中位数(IQR),安慰剂组为 2(2-4)和羟甲唑啉组为 2(2-4),p=0.36]、疼痛 VAS[中位数(IQR),安慰剂组为 2(1-2)和羟甲唑啉组为 2(1-3),p=0.28]、创伤 VAS[中位数(IQR),安慰剂组为 1(0-2)和羟甲唑啉组为 1(0-1),p=0.28]、血流动力学变化或两组之间的并发症。

结论

本研究结果不支持在软性支气管镜检查中使用局部鼻用羟甲唑啉。

试验注册

该试验于 2018 年 1 月 2 日在 Clinicaltrials.gov 上注册,www.clinicaltrials.govNCT03424889。

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