Wang Zhi-Hong, Yang Yi, Xu Gui-Ping
Department of Anesthesia, The People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China.
Medicine (Baltimore). 2017 Mar;96(11):e6256. doi: 10.1097/MD.0000000000006256.
The aim of the study was to assess the efficacy and safety of remifentanil for pain relief during external cephalic version (ECV) for breech presentation in nulliparous women at term.
A total of 144 nulliparous women with singleton breech presentation were randomly divided into the intervention group and the placebo group, with 72 subjects in each group. The subjects in the intervention group received remifentanil (infused at 0.1 μg kg min with demand boluses of 0.1 μg/kg), whereas those in the placebo group were given saline placebo. This study was conducted from May 2013 to April 2016. The outcomes measures include pain (measured with the visual analog scale, VAS), success rate of ECV, maternal satisfaction for ECV, and adverse events.
A total of 137 participants completed the study. The intervention with remifentanil showed greater efficacy than did placebo in decreasing the VAS score immediately after ECV (intervention group 4.3 ± 2.2 vs placebo group 6.4 ± 2.5, P < 0.01). A significant difference in the ECV success rate was also found between the 2 groups (intervention group 56.9% vs placebo group 38.9%, P = 0.03). In addition, a significant difference in the satisfaction score was also detected (intervention group 9.3 ± 0.9 vs placebo group 6.7 ± 1.2, P < 0.01). The observed adverse events were similar between the 2 groups.
This study shows that remifentanil could decrease pain, improve the ECV success rate, and improve satisfaction in nulliparous women at term during the period of ECV. Furthermore, it is also well tolerated with few adverse events.
本研究旨在评估瑞芬太尼用于足月未产妇臀先露外倒转术（ECV）时缓解疼痛的有效性和安全性。
总共144名单胎臀先露的未产妇被随机分为干预组和安慰剂组，每组72名受试者。干预组受试者接受瑞芬太尼（以0.1μg·kg⁻¹·min的速度输注，按需推注0.1μg/kg），而安慰剂组受试者给予生理盐水安慰剂。本研究于2013年5月至2016年4月进行。观察指标包括疼痛（采用视觉模拟评分法，VAS）、ECV成功率、产妇对ECV的满意度以及不良事件。
共有137名参与者完成了研究。瑞芬太尼干预在ECV后即刻降低VAS评分方面显示出比安慰剂更高的疗效（干预组4.3±2.2 vs安慰剂组6.4±2.5，P<0.01）。两组之间在ECV成功率上也发现有显著差异（干预组56.9% vs安慰剂组38.9%，P=0.03）。此外，在满意度评分上也检测到显著差异（干预组9.3±0.9 vs安慰剂组6.7±1.2，P<0.01）。两组观察到的不良事件相似。
本研究表明，瑞芬太尼可减轻足月未产妇在ECV期间的疼痛，提高ECV成功率，并提高满意度。此外，其耐受性良好，不良事件较少。
