Effect of Atropine With Propofol vs Atropine With Atracurium and Sufentanil on Oxygen Desaturation in Neonates Requiring Nonemergency Intubation A Randomized Clinical Trial
Effect of Atropine With Propofol vs Atropine With Atracurium and Sufentanil on Oxygen Desaturation in Neonates Requiring Nonemergency Intubation A Randomized Clinical Trial
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DOI：
10.1001/jama.2018.3708
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发表时间：
2018-05-01
影响因子：
120.7
通讯作者：
Danan, Claude
中科院分区：
文献类型：
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作者：
Durrmeyer, Xavier;Breinig, Sophie;Danan, Claude
重要性 异丙酚或合成阿片类药物和肌肉松弛剂的组合均被推荐用于新生儿插管前的术前用药，但尚未进行比较。目的 比较阿托品-丙泊酚术前用药与阿托品-阿曲库铵-舒芬太尼治疗后新生儿经鼻气管插管期间长时间的饱和度下降。 设计、设置和参与者 多中心、双盲、随机临床试验(2012-2016) 在法国的 6 个 NICU 中进行，其中包括 173 名需要非紧急插管的新生儿。由于研究试剂盒过期和缺乏资金，该研究被中断。 干预措施 在鼻气管插管前，89 名参与者被随机分配到阿托品-丙泊酚组，82 名参与者分配到阿托品-阿曲库铵-舒芬太尼组。 主要结果和措施 主要结果是使用混合模型进行意向治疗分析，延长去饱和度 (SpO(2)（60 秒）。结果评估了手术的特点及其耐受性。 结果 随机分配的 173 名新生儿（平均胎龄 30.6 周；平均出生体重 1502 克；71 名女孩）中，89 名婴儿中有 171 名（99%）完成了试验，阿托品-异丙酚组有 53 名（59.6%），而阿托品-异丙酚组有 54 名（65.9%）。阿托品-阿曲库铵-舒芬太尼组达到了主要结果（调整后的 RD，-6.4；95% CI，-21.0 至 8.1；P = 0.38）。阿托品-丙泊酚组的平均手术持续时间比阿托品-阿曲库铵-舒芬太尼组更长（调整后的 RD，1.7 分钟；95% CI，0.1-3.3 分钟；P = 0.38）。 .04)；镇静质量优良率较低，51.7%（87 人中的 45 人）对比 92.6%（81 人中的 75 人；P < .001）；呼吸恢复中位时间较短，为 14 分钟（IQR，8-34 分钟）与 33 分钟（IQR，15-56 分钟；P = .002），肢体运动恢复中位时间较短，为 18 分钟（IQR，10-43 分钟）对比 36 分钟（IQR，19-65 分钟；P = 0.003）。在纳入后 60 分钟内，阿托品-异丙酚组的 SpO(2) 保持得更好（时间 x 治疗相互作用 P = 0.02）。阿托品-异丙酚组中 20.6% 的头部超声扫描显示颅内出血恶化（任何或增加的脑室内出血）。随机化后 7 天发生严重不良事件，而阿托品-阿曲库铵-舒芬太尼组为 17.6%（调整后的 RD，1.2；95% CI，-13.1 至 15.5，P = 0.87）。阿托品-异丙酚组有 11% 发生严重不良事件，阿托品-阿曲库铵-舒芬太尼组有 20% 发生严重不良事件。结论和相关性 在接受非紧急经鼻气管插管的新生儿中，阿托品与丙泊酚联用或阿托品与阿曲库铵和舒芬太尼联用之间长时间去饱和的频率没有显着差异，但该研究可能不足以检测临床上的重要差异，可能需要进一步研究。
IMPORTANCE Propofol or a combination of a synthetic opioid and muscle relaxant are both recommended for premedication before neonatal intubation but have yet to be compared.OBJECTIVE To compare prolonged desaturation during neonatal nasotracheal intubation after premedication with atropine-propofol vs atropine-atracurium-sufentanil treatment.DESIGN, SETTING, AND PARTICIPANTS Multicenter, double-blind, randomized clinical trial (2012-2016) in 6 NICUs in France that included 173 neonates requiring nonemergency intubation. The study was interrupted due to expired study kits and lack of funding.INTERVENTIONS Eighty-nine participants were randomly assigned to the atropine-propofol group and 82 to the atropine-atracurium-sufentanil group before nasotracheal intubation.MAIN OUTCOMES AND MEASURES The primary outcome was prolonged desaturation (SpO(2) ( 60 seconds), using intention-to-treat analysis using mixed models. Secondary outcomes assessed the characteristics of the procedure and its tolerance.RESULTS Of 173 neonates randomized (mean gestational age, 30.6 weeks; mean birth weight, 1502 g; 71 girls), 171 (99%) completed the trial. Of 89 infants, 53 (59.6%) in the atropine-propofol group vs 54 of 82 (65.9%) in the atropine-atracurium-sufentanil group achieved the primary outcome (adjusted RD, -6.4; 95% CI, -21.0 to 8.1; P = .38). The atropine-propofol group had a longer mean procedure duration than did the atropine-atracurium-sufentanil group (adjusted RD, 1.7 minutes; 95% CI, 0.1-3.3 minutes; P = .04); a less frequent excellent quality of sedation rate, 51.7%(45 of 87) vs 92.6%(75 of 81; P < .001); a shorter median time to respiratory recovery, 14 minutes (IQR, 8-34 minutes) vs 33 minutes (IQR, 15-56 minutes; P = .002), and shorter median time to limb movement recovery, 18 minutes (IQR, 10-43 minutes) vs 36 minutes (IQR, 19-65 minutes; P = .003). In the 60 minutes after inclusion, SpO(2) was preserved significantly better in the atropine-propofol group (time x treatment interaction P = .02). Of the atropine-propofol group 20.6% had head ultrasound scans that showed worsening intracranial hemorrhaging (any or increased intraventricular hemorrhage) in the 7 days after randomization vs 17.6% in the atropine-atracurium-sufentanil group (adjusted RD, 1.2; 95% CI, -13.1 to 15.5, P = .87). Severe adverse events occurred in 11% of the atropine-propofol group and in 20% of the atropine-atracurium-sufentanil group.CONCLUSIONS AND RELEVANCE Among neonates undergoing nonemergency nasotracheal intubation, the frequency of prolonged desaturation did not differ significantly between atropine used with propofol or atropine used with atracurium and sufentanil. However, the study may have been underpowered to detect a clinically important difference, and further research may be warranted.