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评价灌注指数预测儿童锁骨上臂丛阻滞效果的随机试验方案

Evaluation of prediction effect of perfusion index for supraclavicular brachial plexus block in children: protocol for a randomized trial.

机构信息

Department of Anesthesiology and Pain Medicine, Tongji Hospital, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan, 430030, China.

出版信息

Trials. 2022 Aug 4;23(1):629. doi: 10.1186/s13063-022-06597-y.

Abstract

BACKGROUND

Pulse perfusion index (PI) reflects blood perfusion. It has been reported that PI can be used to evaluate the effect of nerve block, but currently, it is mainly focused on awake adults. In pediatric general anesthesia, it has been reported that PI can evaluate the effect of the sacral block. Still, there is a lack of relevant research on the impact of brachial plexus blocks. Our objective is to assess the prediction effects of PI on the success of supraclavicular brachial plexus block in pediatric patients under sevoflurane or propofol general anesthesia.

METHODS/DESIGN: This is a mono-center, parallel, 2-arm randomized superiority trial. One hundred four children aged 1 month to 12 years who undergo upper limb surgery will be enrolled in this study. According to anesthesia induction and maintenance medication, they will be divided into sevoflurane and propofol groups. The PI values of the index and little finger will be recorded on the blocked and non-blocked sides of supraclavicular brachial plexus block (SCB) in all children. The primary outcome is to assess the effects of PI on the success of supraclavicular brachial plexus block in pediatric patients under sevoflurane or propofol general anesthesia. The secondary outcome includes mean arterial blood pressure (MAP), heart rate (HR), and correlation between baseline PI and 10 min after SCB (PI ratio).

DISCUSSION

This trial will provide evidence on the changes in PI after SCB in sevoflurane or propofol anesthesia in children. SCB may lead to changes in PI values under sevoflurane or propofol anesthesia. After the children wake up at the end of the surgery, the changes in PI values on the block side and non-block side may be helpful to judge the effect of nerve block when excluding the influence of anesthetics.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04216823 . Registered on 15 July 2020.

摘要

背景

脉搏灌注指数(PI)反映血液灌注情况。有报道称 PI 可用于评估神经阻滞的效果,但目前主要集中在清醒的成年人。在小儿全身麻醉中,已有报道称 PI 可用于评估骶神经阻滞的效果,但对于臂丛神经阻滞的效果评估,相关研究较少。本研究旨在评估 PI 对七氟醚或丙泊酚全身麻醉下小儿锁骨上臂丛阻滞效果的预测作用。

方法/设计:这是一项单中心、平行、2 臂随机优效性试验。将纳入 104 例行上肢手术的 1 个月至 12 岁儿童。根据麻醉诱导和维持药物的不同,将其分为七氟醚组和丙泊酚组。所有儿童均记录锁骨上臂丛阻滞(SCB)阻滞侧和非阻滞侧的食指和小指 PI 值。主要结局是评估 PI 对七氟醚或丙泊酚全身麻醉下小儿锁骨上臂丛阻滞效果的影响。次要结局包括平均动脉压(MAP)、心率(HR)以及 SCB 前后的基础 PI 值与 10 min 后 PI 值的相关性(PI 比值)。

讨论

本试验将提供小儿 SCB 后七氟醚或丙泊酚麻醉下 PI 变化的证据。SCB 可能导致七氟醚或丙泊酚麻醉下 PI 值的变化。手术结束后,患儿苏醒时,阻滞侧和非阻滞侧 PI 值的变化有助于在排除麻醉药物影响的情况下判断神经阻滞的效果。

试验注册

ClinicalTrials.gov NCT04216823,于 2020 年 7 月 15 日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/665e/9351202/96b4e4c53047/13063_2022_6597_Fig1_HTML.jpg

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