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罗哌卡因联合舒芬太尼与罗哌卡因联合右美托咪定用于分娩硬膜外镇痛的比较:一项随机对照试验方案

Comparison of ropivacaine plus sufentanil and ropivacaine plus dexmedetomidine for labor epidural analgesia: A randomized controlled trial protocol.

作者信息

Chen Gang, Gong Maowei, Liu Yi

机构信息

Department of Anesthesia, The First Medical Center of Chinese PLA General Hospital, Beijing 100853, China.

出版信息

Medicine (Baltimore). 2020 Sep 4;99(36):e22113. doi: 10.1097/MD.0000000000022113.

Abstract

OBJECTIVE

Effective analgesia during delivery can not only decrease pain, but also have a significant function in ensuring the safety of baby and mother. Sufentanil is generally used opioid with ropivacaine in epidural anesthesia in labor pain management; however it can cause some adverse reaction. Dexmedetomidine is an a2-adrenoceptor agonist with high selectivity. It possesses opioid-sparing and analgesic effects and it is suitable for the long-term and short-term intraoperative sedation. The purpose of this present study is to compare the analgesic effect of ropivacaine with dexmedetomidine against ropivacaine with sufentanyl in epidural labor.

METHODS

This is a single center, placebo-controlled randomized trial which will be performed from May 2020 to May 2021. It was authorized via the Institutional Review Committee in the first medical center of Chinese PLA General Hospital (S2018-211-0). One hundred sixty full-term protozoa are included in this work. They are randomly divided into four groups (n = 40 per group): the RD1 group (with the epidural administration of 0.125% ropivacaine + dexmedetomidine of 0.5 μg/mL), and the RD2 group (with the epidural administration of 0.08% ropivacaine + dexmedetomidine 0.5 μg/mL), the RS1 group (with the epidural administration of 0.125% ropivacaine + sufentanil of 0.5 μg/mL), as well as RS2 group (with the epidural administration of 0.08% ropivacaine + sufentanil of 0.5 μg/mL). Clinical outcomes are pain score, a modified Bromage scale, the Ramsay Sedation Scale, and adverse reactions during analgesia. All the needed analyses are implemented through utilizing SPSS for Windows Version 20.0.

RESULTS

The first table shows the clinical outcomes between these four groups.

CONCLUSION

This current work can provide a primary evidence regarding the clinical outcomes of dexmedetomidine versus sufentanil for labor epidural analgesia.

TRIAL REGISTRATION

This study protocol was registered in Research Registry (researchregistry5877).

摘要

目的

分娩期间有效的镇痛不仅可以减轻疼痛,而且在确保母婴安全方面具有重要作用。舒芬太尼是分娩镇痛硬膜外麻醉中常用的阿片类药物,与罗哌卡因联合使用;然而,它可能会引起一些不良反应。右美托咪定是一种高选择性的α2肾上腺素能受体激动剂。它具有节省阿片类药物和镇痛作用,适用于术中短期和长期镇静。本研究的目的是比较罗哌卡因联合右美托咪定与罗哌卡因联合舒芬太尼在硬膜外分娩镇痛中的效果。

方法

这是一项单中心、安慰剂对照的随机试验,将于2020年5月至2021年5月进行。该试验已获得中国人民解放军总医院第一医学中心机构审查委员会的批准(S2018-211-0)。本研究纳入160例足月产妇。她们被随机分为四组(每组n = 40):RD1组(硬膜外注射0.125%罗哌卡因+0.5μg/mL右美托咪定)、RD2组(硬膜外注射0.08%罗哌卡因+0.5μg/mL右美托咪定)、RS1组(硬膜外注射0.125%罗哌卡因+0.5μg/mL舒芬太尼)以及RS2组(硬膜外注射0.08%罗哌卡因+0.5μg/mL舒芬太尼)。临床结局指标包括疼痛评分、改良的布罗麦格量表、 Ramsay镇静量表以及镇痛期间的不良反应。所有所需分析均通过使用SPSS for Windows 20.0版本进行。

结果

第一个表格显示了这四组之间的临床结局。

结论

本研究可为右美托咪定与舒芬太尼用于分娩硬膜外镇痛的临床结局提供初步证据。

试验注册

本研究方案已在Research Registry(researchregistry5877)注册。

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