在剖腹产期间预防性输注苯肾上腺素和去甲肾上腺素以防止胎儿心率不稳定:一项评估新生儿结局的随机非劣效性试验。

IF 6.8 2区 医学 Q1 ANESTHESIOLOGY
Nitika Goel, Heena Sharma, Kajal Jain, Anudeep Jafra, Shalini Gainder, Praveen Kumar
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引用次数: 0

摘要

背景:苯肾上腺素被推荐用于剖宫产妇女脊柱麻醉后低血压的治疗。去甲肾上腺素是一种肾上腺素能激动剂,具有较弱的β-肾上腺素活性,据报道,它比苯肾上腺素具有更有利的血流动力学特征。然而,有人担心去甲肾上腺素可能与胎儿酸中毒的高风险有关,这在已经受损的胎儿中可能是严重的。目的:本研究旨在验证剖宫产时过量去甲肾上腺素预防脊柱低血压在脐动脉基底上并不亚于苯肾上腺素的假设。设计:前瞻性、随机、双盲试验。地点:2022年1月至2022年11月,印度北部三级医院手术室。患者:在脊髓麻醉下进行非选择性剖宫产的胎儿心率不稳定的产妇。干预:采用预先设定的算法,给予同等效力的预防性输注苯肾上腺素80 μg min-1或去甲肾上腺素6 μg min-1,以维持母体收缩压在基线的90 - 110%之间。主要转归指标:主要转归指标为脐动脉基底过量,将95%置信区间的界限与预先设定的-0.05 mmol -1的非劣效性界限进行比较。同时对去甲肾上腺素组和苯肾上腺素组胎儿酸中毒发生率进行评价。结果:对104例患者资料进行分析。去甲肾上腺素组脐动脉基底过量平均值±SD高于苯肾上腺素组:-6.85±2.20 mmol l-1vs。分别为-7.95±2.99更易与l - 1 (P = 0.034)。去甲肾上腺素是非劣效性的,因为两组基线过量的平均差异的95% CI下限为1.10 (95% CI, 0.084至2.123)mmol -1, P = 0.034),没有超过我们预先设定的-0.05 mmol -1的非劣效性界限。去甲肾上腺素组与苯肾上腺素组胎儿酸中毒发生率无显著差异:62% vs. 75% (P = 0.140)。结论:预防性输注去甲肾上腺素(6 μg min-1)与输注苯肾上腺素(80 μg min-1)在脐动脉基底过量值方面无明显差异。两组胎儿酸中毒发生率相似。试验注册:CTRI/2022/01/039343;日期- 2022年1月12日。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Prophylactic phenylephrine and norepinephrine infusions during caesarean delivery for non-reassuring fetal heart rate: A randomised noninferiority trial to assess neonatal outcome.

Background: Phenylephrine is recommended for the management of hypotension after spinal anaesthesia for women undergoing caesarean delivery. Norepinephrine, an adrenergic agonist with weak β-adrenergic activity, has been reported to have a more favourable haemodynamic profile than phenylephrine. However, there are concerns that norepinephrine may be associated with higher risk of fetal acidosis which can be serious in an already compromised foetus.

Objective: This study aimed to test the hypothesis that in terms of the umbilical artery base excess norepinephrine is not inferior to phenylephrine when it is used to prevent spinal hypotension during caesarean delivery.

Design: A prospective, randomised, double-blind trial.

Setting: Operating room of Tertiary Care Hospital in Northern India from January 2022 to November 2022.

Patients: Parturients with non-reassuring fetal heart rate undergoing nonelective caesarean delivery under spinal anaesthesia.

Intervention: Equipotent prophylactic infusions of either phenylephrine 80 μg min-1 or norepinephrine 6 μg min-1 were administered to maintain maternal systolic BP between 90 and 110% of baseline using a predefined algorithm.

Main outcome measures: The primary outcome was umbilical arterial base excess comparing the limits of the 95% confidence interval with a predefined noninferiority margin of -0.05 mmol l-1. The incidence of fetal acidosis was also evaluated for norepinephrine and phenylephrine group.

Results: Data were analysed from 104 patients. The mean ± SD umbilical arterial base excess was higher in norepinephrine group than the phenylephrine group: -6.85 ± 2.20 mmol l-1vs. -7.95 ± 2.99 mmol l-1, respectively (P  = 0.034). Norepinephrine was found to be noninferior as the lower limit of 95% CI of mean difference between base excess of two groups was 1.10 (95% CI, 0.084 to 2.123) mmol l-1, P  = 0.034) which did not cross our predefined noninferiority margin of -0.05 mmol l-1. No significant difference in the incidence of fetal acidosis was observed between norepinephrine and phenylephrine groups: 62% vs. 75% (P  = 0.140).

Conclusion: Prophylactic norepinephrine infusion (6 μg min-1) was found to be noninferior to phenylephrine infusion (80 μg min-1) in terms of umbilical arterial base excess values. A similar incidence of fetal acidosis was observed in both groups.

Trial registration: CTRI/2022/01/039343; dated - 12 January 2022.

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来源期刊
CiteScore
6.90
自引率
11.10%
发文量
351
审稿时长
6-12 weeks
期刊介绍: The European Journal of Anaesthesiology (EJA) publishes original work of high scientific quality in the field of anaesthesiology, pain, emergency medicine and intensive care. Preference is given to experimental work or clinical observation in man, and to laboratory work of clinical relevance. The journal also publishes commissioned reviews by an authority, editorials, invited commentaries, special articles, pro and con debates, and short reports (correspondences, case reports, short reports of clinical studies).
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