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剖宫产脊髓麻醉前6%羟乙基淀粉(130/0.4)与乳酸林格氏液预负荷的比较:随机、双盲、多中心CAESAR试验

6% Hydroxyethyl starch (130/0.4) vs Ringer's lactate preloading before spinal anaesthesia for Caesarean delivery: the randomized, double-blind, multicentre CAESAR trial.

作者信息

Mercier F J, Diemunsch P, Ducloy-Bouthors A-S, Mignon A, Fischler M, Malinovsky J-M, Bolandard F, Aya A G, Raucoules-Aimé M, Chassard D, Keita H, Rigouzzo A, Le Gouez A

机构信息

Département d'Anesthésie-Réanimation, Université Paris-Sud, APHP-Hôpital Antoine Béclère, 157 rue de la Porte de Trivaux, 92141 Clamart, France

Département d'Anesthésie-Réanimation, Hôpital de Hautepierre, 67000 Strasbourg, France.

出版信息

Br J Anaesth. 2014 Sep;113(3):459-67. doi: 10.1093/bja/aeu103. Epub 2014 Jun 26.

DOI:10.1093/bja/aeu103
PMID:24970272
Abstract

BACKGROUND

Vasopressor administration is recommended to prevent hypotension during spinal anaesthesia (SA) for elective Caesarean delivery. We aimed to test the superior efficacy and ensure safety of a hydroxyethyl starch (HES) vs a Ringer's lactate (RL) preloading, when combined with a phenylephrine-based prophylaxis.

METHODS

A total of 167 healthy parturients undergoing elective Caesarean delivery under SA were included in this multicentre, randomized, double-blind study. Patients received 500 ml of 6% HES (130/0.4)+500 ml of RL (HES group) or 1000 ml of RL (RL group) i.v. before SA. After SA, i.v. phenylephrine boluses were titrated when systolic arterial pressure (SAP) was below 95% of baseline. The primary outcome was the incidence of maternal hypotension (SAP <80% of baseline).

RESULTS

The incidence of both hypotension and symptomatic hypotension (i.e. with dizziness, nausea/vomiting, or both) was significantly lower in the HES group vs the RL group: 36.6% vs 55.3% (one-sided P=0.025) and 3.7% vs 14.1%. There was no significant difference in total phenylephrine requirements [median (range): 350 (50-1800) vs 350 (50-1250) µg]. The decrease in maternal haemoglobin value the day after surgery was similar in the two groups [1.2 (1.0) vs 1.0 (0.9) g dl(-1)]. There was no detectable placental transfer of HES in six umbilical cord blood samples analysed in the HES group. Neonatal outcomes were comparable between the groups.

CONCLUSIONS

Compared with a pure RL preloading, a mixed HES-RL preloading significantly improved prevention of both hypotension and symptomatic hypotension based on early phenylephrine bolus administration and did not induce adverse effects.

CLINICAL TRIAL REGISTRATION

NCT00694343 (http://clinicaltrials.gov).

摘要

背景

建议使用血管升压药预防择期剖宫产脊髓麻醉(SA)期间的低血压。我们旨在测试羟乙基淀粉(HES)与乳酸林格氏液(RL)预负荷联合基于去氧肾上腺素的预防措施时的卓越疗效并确保安全性。

方法

本多中心、随机、双盲研究纳入了167例在SA下接受择期剖宫产的健康产妇。患者在SA前静脉输注500ml 6% HES(130/0.4)+500ml RL(HES组)或1000ml RL(RL组)。SA后,当收缩压(SAP)低于基线的95%时,静脉推注去氧肾上腺素进行滴定。主要结局是产妇低血压(SAP<基线的80%)的发生率。

结果

HES组低血压和症状性低血压(即伴有头晕、恶心/呕吐或两者兼有)的发生率均显著低于RL组:分别为36.6%对55.3%(单侧P=0.025)和3.7%对14.1%。去氧肾上腺素总需求量无显著差异[中位数(范围):350(50 - 1800)对350(50 - 1250)μg]。两组术后第一天产妇血红蛋白值的下降相似[1.2(1.0)对1.0(0.9)g dl⁻¹]。HES组分析的6份脐血样本中未检测到HES的胎盘转运。两组间新生儿结局相当。

结论

与单纯RL预负荷相比,HES - RL混合预负荷基于早期静脉推注去氧肾上腺素显著改善了低血压和症状性低血压的预防,且未引起不良反应。

临床试验注册

NCT00694343(http://clinicaltrials.gov)

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