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.

中文翻译：

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低剂量瑞芬太尼在全身麻醉早产剖宫产术中的应用：一项随机对照试验

背景和目的

剖腹产期间全身麻醉诱导的传统技术仅在脐带夹紧后使用阿片类药物。我们假设在断脐前使用瑞芬太尼可能会减少母体补充麻醉剂的使用，并改善母体血流动力学状态和早产儿的新生儿适应。

方法

一项 III 期、双盲、随机、安慰剂对照、以医院为基础的试验纳入了在妊娠 37 周前接受全身麻醉剖腹产的产妇。分组随机化将孕妇分配至瑞芬太尼或安慰剂。主要结局是 5 分钟时 Apgar 评分 < 7 的新生儿比例。次要结局是产妇血流动力学参数、麻醉诱导并发症、辅助麻醉剂的使用、新生儿呼吸窘迫、脐带 pH 值和乳酸水平。

结果

总共对 52/55 名参与者进行了分析，其中瑞芬太尼组有 27 名女性，安慰剂组有 25 名女性。瑞芬太尼组 27 名新生儿中有 9 名 (33.3%) 在 5 分钟时阿普加评分 < 7，而安慰剂组为 11/25 (44.0%)（p = 0.45，比值比 = 0.66，95 置信区间0.20–2.18  ） 。校正年龄 1 岁和 2 岁时，血带气体、认知、行为、感觉、睡眠和喂养评分没有差异。对于母亲来说，血流动力学参数、麻醉持续时间和脐带结扎前的累积治疗剂量在各组之间没有差异。

结论

剖宫产钳夹脐带前使用低剂量的瑞芬太尼似乎对母亲和早产儿都是安全的，但它并不能改善孕产妇或新生儿的结局。

临床试验注册

ClinicalTrials.gov：NCT02029898。