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瑞芬太尼与神经肌肉阻滞剂联合应用于小儿气管插管的效果:一项前瞻性、双盲、随机临床试验。

Effect of the combination of remifentanil and neuromuscular blockers in pediatric endotracheal intubation: a prospective, double-blinded, randomized clinical trial.

作者信息

Qiao Lanxin, Zhang Di, Gao Zhengzheng, Zi Tingting, Zhang Jianmin, Li Lijing, Wang Fang

机构信息

Department of Anesthesiology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, 100045, China.

Department of Anesthesiology, The First Hospital of Tsinghua University, Beijing, 100016, China.

出版信息

BMC Pediatr. 2025 Aug 18;25(1):629. doi: 10.1186/s12887-025-06010-y.

Abstract

BACKGROUND

Endotracheal intubation must be performed more carefully in children than in adults, as children are likely to more serious consequences due to the buck, move, and hemodynamic changes during the procedure. The aim of this study was to explore whether increasing the use of remifentanil during anesthesia induction can further improve the effectiveness and safety of tracheal intubation in children.

DESIGN

This double-blind clinical trial included patients who underwent elective surgery under general anesthesia for intubation at Beijing Children's Hospital.

METHODS

One hundred thirty-eight pediatric patients aged 1-12 years, classified as having American Society of Anesthesiologists (ASA) physical status I or II, who received general anesthetics for elective surgery were randomly divided into a remifentanil group (group R) (n = 69) and a placebo group (group C) (n = 69). In group R, 1 µg/kg remifentanil was intravenously infused after the intravenous infusion of other induction drugs. In group C, the same volume of normal saline was injected intravenously. The primary outcome measure was successful intubation at the first attempt with no adverse events.

RESULTS

In total, 129 patients (64 in the group R and 65 in the group C) were enrolled. The incidence of first-attempt successful tracheal intubation with no adverse events was greater in group R (87.5%, n = 56) than in group C (60.0%, n = 39) (OR, 4.7; 95% CI = 1.9-11.4; p < 0.001).

CONCLUSIONS

Compared with the use of cisatracurium alone, the combination of low-dose remifentanil with cisatracurium was associated with a higher rate of successful first-attempt intubation without adverse events.

TRIAL REGISTRATION

Chinese Clinical Trial Registry. Retrospectively registered. Identifier: ChiCTR2400089691. Date: 13/9/2024.

摘要

背景

与成人相比,儿童气管插管操作必须更加谨慎,因为在插管过程中,儿童可能因身体扭动、移动及血流动力学变化而出现更严重的后果。本研究旨在探讨在麻醉诱导期间增加瑞芬太尼的使用量是否能进一步提高儿童气管插管的有效性和安全性。

设计

这项双盲临床试验纳入了在北京儿童医院接受全身麻醉下择期手术插管的患者。

方法

138例年龄在1至12岁、美国麻醉医师协会(ASA)身体状况为I或II级、接受全身麻醉进行择期手术的儿科患者被随机分为瑞芬太尼组(R组)(n = 69)和安慰剂组(C组)(n = 69)。在R组中,在静脉输注其他诱导药物后静脉输注1μg/kg瑞芬太尼。在C组中,静脉注射相同体积的生理盐水。主要观察指标是首次尝试插管成功且无不良事件。

结果

总共纳入了129例患者(R组64例,C组65例)。R组首次尝试气管插管成功且无不良事件的发生率(87.5%,n = 56)高于C组(60.0%,n = 39)(OR,4.7;95%CI = 1.9 - 11.4;p < 0.001)。

结论

与单独使用顺式阿曲库铵相比,低剂量瑞芬太尼与顺式阿曲库铵联合使用时首次尝试插管成功且无不良事件的发生率更高。

试验注册

中国临床试验注册中心。回顾性注册。标识符:ChiCTR2400089691。日期:2024年9月13日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/19c7/12359987/b5e20a7f6f67/12887_2025_6010_Fig1_HTML.jpg

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