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地塞米松-罗哌卡因与舒芬太尼-罗哌卡因用于硬膜外分娩镇痛的疗效和安全性:一项随机对照试验。

Efficacy and safety of dexmedetomidine-ropivacaine versus sufentanil-ropivacaine for epidural labor analgesia: a randomized controlled trial.

机构信息

Department of Anesthesiology, The Affiliated Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu Women's and Children's Central Hospital, Chengdu, China.

Department of Anesthesiology, Chengdu Fifth People's Hospital. Chengdu, China.

出版信息

Ann Palliat Med. 2022 Apr;11(4):1410-1420. doi: 10.21037/apm-22-264.

DOI:10.21037/apm-22-264
PMID:35523749
Abstract

BACKGROUND

Sufentanil combined with ropivacaine is commonly used for epidural labor analgesia, but it may cause some adverse effects. Dexmedetomidine is suitable for long-term and short-term intraoperative sedation and analgesia, and it can reduce the use of the opioid sufentanil. This study compared the efficacy and safety of dexmedetomidine and sufentanil combined with ropivacaine for epidural labor analgesia.

METHODS

A randomized, triple-blinded, controlled trial was performed for epidural labor analgesia. All included parturient women were randomized 1:1 by computer to receive ropivacaine combined with dexmedetomidine (group RD) or sufentanil (group RS) from October 2020 to February 2021. The primary outcomes were the pain relief of parturient women assessed by the visual analog scale (VAS) score, and the physical status of newborns assessed by the neonatal behavioral neurological assessment (NBNA) score and Apgar score. Secondary outcomes included the duration of labor stages and adverse reactions of parturient women and newborns.

RESULTS

A total of 160 parturient women were included in this study, with 80 in each group. The VAS scores were lower in both groups after the injection of analgesics (in 120 min; RD: 2.6±1.0 vs. RS: 2.5±0.8; P=0.489), and there was no significant difference. The newborns' NBNA (RD: 39.9±0.4 vs. RS: 39.8±0.5; P=0.368) and Apgar scores (RD: 9.8±0.7 vs. RS: 9.7±0.8; P=0.424) were higher than normal standard (NBNA >37; Apgar >7) in both groups, and there were also no significant differences. No differences in parturient women's demographic characteristics, vital signs, Ramsay Sedation Scale (RSS) values, blood loss, duration of labor stages (first and second stages), onset time of analgesia, and dose of analgesics were found between the 2 groups (all P>0.05). The incidence of adverse reactions in parturient women and newborns was low in both groups.

CONCLUSIONS

Dexmedetomidine or sufentanil combined with ropivacaine for epidural labor analgesia had similar analgesic effects in clinical practice.

TRIAL REGISTRATION

Chinese Clinical Trial Registry ChiCTR2000038702.

摘要

背景

舒芬太尼联合罗哌卡因常用于硬膜外分娩镇痛,但可能会引起一些不良反应。右美托咪定适合用于长期和短期的术中镇静和镇痛,并且可以减少阿片类药物舒芬太尼的使用。本研究比较了右美托咪定和舒芬太尼联合罗哌卡因用于硬膜外分娩镇痛的效果和安全性。

方法

这是一项硬膜外分娩镇痛的随机、三盲、对照试验。2020 年 10 月至 2021 年 2 月,所有纳入的产妇均通过计算机按 1:1 随机分为罗哌卡因联合右美托咪定(RD 组)或舒芬太尼(RS 组)。主要结局是视觉模拟评分(VAS)评估的产妇镇痛效果,新生儿行为神经评估(NBNA)评分和 Apgar 评分评估的新生儿生理状态。次要结局包括产妇和新生儿的产程时间和不良反应。

结果

本研究共纳入 160 例产妇,每组 80 例。两组产妇在注射镇痛药物后 VAS 评分均较低(120 分钟时:RD 组 2.6±1.0 分,RS 组 2.5±0.8 分;P=0.489),且差异无统计学意义。两组新生儿的 NBNA(RD 组 39.9±0.4 分,RS 组 39.8±0.5 分;P=0.368)和 Apgar 评分(RD 组 9.8±0.7 分,RS 组 9.7±0.8 分;P=0.424)均高于正常标准(NBNA>37 分;Apgar>7 分),且差异无统计学意义。两组产妇的人口统计学特征、生命体征、Ramsay 镇静评分(RSS)值、出血量、产程时间(第一产程和第二产程)、镇痛起效时间和镇痛药物剂量均无差异(均 P>0.05)。两组产妇和新生儿的不良反应发生率均较低。

结论

在临床实践中,右美托咪定或舒芬太尼联合罗哌卡因用于硬膜外分娩镇痛的镇痛效果相似。

试验注册

中国临床试验注册中心 ChiCTR2000038702。

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