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三种诱导方案(使用琥珀酰胆碱、维库溴铵或不使用肌松剂)的比较:对面肌痉挛手术中侧方扩散反应术中监测的影响:一项随机对照试验的研究方案。

A comparison of three induction regimens using succinylcholine, vecuronium, or no muscle relaxant: impact on the intraoperative monitoring of the lateral spread response in hemifacial spasm surgery: study protocol for a randomised controlled trial.

机构信息

Department of Neurosurgery, West China Hospital, Sichuan University, 37 Guo Xue Xiang Street, Chengdu 610041, China.

出版信息

Trials. 2012 Sep 8;13:160. doi: 10.1186/1745-6215-13-160.

Abstract

BACKGROUND

Surgical microvascular decompression (MVD) is the curative treatment for hemifacial spasm (HFS). Monitoring MVD by recording the lateral spread response (LSR) intraoperatively can predict a successful clinical outcome. However, the rate of the LSR varies between trials, and the reason for this variation is unclear. The aim of our trial is to evaluate the rate of the LSR after intubation following treatment with succinylcholine, vecuronium, or no muscle relaxant.

METHODS AND DESIGN

This trial is a prospective randomised controlled trial of 96 patients with HFS (ASA status I or II) undergoing MVD under general anaesthesia. Patients are randomised to receive succinylcholine, vecuronium, or no muscle relaxant before intubation. Intraoperative LSR will be recorded until dural opening. The primary outcome of this study is the rate of the LSR, and the secondary outcomes are post-intubation pharyngolaryngeal symptoms, the rate of difficult intubations, the rate of adverse haemodynamic events and the relationship between the measurement of LSR or not, and clinical success rates at 30 days after surgery.

DISCUSSION

This study aims to evaluate the impact of muscle relaxants on the rate of the LSR, and the study may provide evidence supporting the use of muscle relaxants before intubation in patients with HFS undergoing MVD surgery.

TRIALS REGISTRATION

http://www.chictr.org/ ChiCTR-TRC-11001504 Date of registration: 24 June, 2011. The date the first patient was randomised: 30 September, 2011.

摘要

背景

显微血管减压术(MVD)是治疗面肌痉挛(HFS)的有效治疗方法。术中通过记录外侧扩散反应(LSR)来监测 MVD 可以预测临床治疗效果。然而,LSR 的发生率在不同的试验中存在差异,其原因尚不清楚。本试验旨在评估在使用琥珀酰胆碱、维库溴铵或不使用肌肉松弛剂进行插管后,LSR 的发生率。

方法和设计

这是一项前瞻性随机对照试验,纳入 96 例 ASA 分级 I 或 II 级的 HFS 患者,在全身麻醉下接受 MVD 治疗。患者随机接受琥珀酰胆碱、维库溴铵或不使用肌肉松弛剂插管。术中记录 LSR 直至硬脑膜切开。本研究的主要结局是 LSR 的发生率,次要结局是插管后咽-喉症状、插管困难的发生率、不良血流动力学事件的发生率以及 LSR 测量与术后 30 天临床成功率之间的关系。

讨论

本研究旨在评估肌肉松弛剂对 LSR 发生率的影响,该研究可能为 MVD 手术中 HFS 患者在插管前使用肌肉松弛剂提供支持证据。

试验注册

http://www.chictr.org/ChiCTR-TRC-11001504 注册日期:2011 年 6 月 24 日。首例患者随机分组日期:2011 年 9 月 30 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2141/3502586/c81c7b290868/1745-6215-13-160-1.jpg

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