Low-Dose Remifentanil in Preterm Cesarean Section with General Anesthesia: A Randomized Controlled Trial.

IF 3.4 3区医学 Q1 PEDIATRICS

Pediatric Drugs Pub Date : 2024-01-01 Epub Date: 2023-09-15 DOI:10.1007/s40272-023-00591-w

Clément Chollat, Fabien Tourrel, Estelle Houivet, Romain Gillet, Eric Verspyck, Maryline Lecointre, Stéphane Marret, Vincent Compère

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引用次数: 0

Abstract

Background and objective: The conventional technique of general anesthesia induction during a Cesarean section involves the use of opioids only after cord clamping. We hypothesized that the use of remifentanil before cord clamping might reduce the use of maternal supplemental anesthetic agents and improve the maternal hemodynamics status and neonatal adaptation of the preterm neonate.

Methods: A phase III, double-blind, randomized, placebo-controlled, hospital-based trial enrolled parturients undergoing a Cesarean section under general anesthesia before 37 weeks of gestation. Block randomization allocated pregnant women to remifentanil or placebo. The primary outcome was the rate of newborns with Apgar scores < 7 at 5 min. Secondary outcomes were maternal hemodynamic parameters, complications of anesthetic induction, use of adjuvant anesthetic agents, neonatal respiratory distress, umbilical cord pH, and lactate levels.

Results: A total of 52/55 participants were analyzed, comprising 27 women in the remifentanil group and 25 in the placebo group. Nine of 27 (33.3%) neonates had an Apgar score < 7 at 5 min in the remifentanil group versus 11/25 (44.0%) in the placebo group (p = 0.45, odds ratio = 0.66, 95 confidence interval 0.20-2.18). The blood cord gases, cognitive, behavior, sensory, sleeping, and feeding scores at 1 and 2 years of corrected age were not different. For the mothers, hemodynamic parameters, anesthesia duration, and the cumulative treatment dose until cord clamping did not differ between the groups.

Conclusions: The use of a low dose of remifentanil before cord clamping for a Cesarean section appears to be safe both for the mother and the preterm newborn, but it does not improve maternal or neonatal outcomes.

Clinical trial registration: ClinicalTrials.gov: NCT02029898.

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低剂量 Remifentanil 在早产儿剖宫产手术中的全身麻醉：随机对照试验

背景和目的：传统的剖宫产全身麻醉诱导技术仅在脐带钳夹后使用阿片类药物。我们假设在脐带钳夹前使用瑞芬太尼可能会减少母体辅助麻醉剂的使用，并改善早产新生儿的母体血流动力学状态和新生儿适应性：一项以医院为基础的 III 期、双盲、随机、安慰剂对照试验招募了妊娠 37 周前在全身麻醉下进行剖宫产的孕妇。采用整群随机法将孕妇分配到瑞芬太尼或安慰剂中。主要结果是新生儿Apgar评分率：共分析了 52/55 名参与者，其中瑞芬太尼组 27 名，安慰剂组 25 名。27 名新生儿中有 9 名（33.3%）Apgar 评分得出结论：在剖宫产钳夹脐带前使用小剂量瑞芬太尼似乎对产妇和早产新生儿都是安全的，但它并不能改善产妇或新生儿的预后：临床试验注册：ClinicalTrials.gov：临床试验注册：ClinicalTrials.gov：NCT02029898。

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来源期刊

Pediatric Drugs PEDIATRICS-PHARMACOLOGY & PHARMACY

CiteScore

7.20

自引率

0.00%

发文量

审稿时长

>12 weeks

期刊介绍： Pediatric Drugs promotes the optimization and advancement of all aspects of pharmacotherapy for healthcare professionals interested in pediatric drug therapy (including vaccines). The program of review and original research articles provides healthcare decision makers with clinically applicable knowledge on issues relevant to drug therapy in all areas of neonatology and the care of children and adolescents. The Journal includes: -overviews of contentious or emerging issues. -comprehensive narrative reviews of topics relating to the effective and safe management of drug therapy through all stages of pediatric development. -practical reviews covering optimum drug management of specific clinical situations. -systematic reviews that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. -Adis Drug Reviews of the properties and place in therapy of both newer and established drugs in the pediatric population. -original research articles reporting the results of well-designed studies with a strong link to clinical practice, such as clinical pharmacodynamic and pharmacokinetic studies, clinical trials, meta-analyses, outcomes research, and pharmacoeconomic and pharmacoepidemiological studies. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Pediatric Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.