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Low-Concentration Norepinephrine Infusion for Major Surgery: A Safety and Feasibility Pilot Randomized Controlled Trial
Anesthesia & Analgesia ( IF 5.7 ) Pub Date : 2021-12-06 , DOI: 10.1213/ane.0000000000005811
Verna M. Aykanat 1 , Paul S. Myles 1 , Laurence Weinberg 2 , Aidan Burrell 3, 4 , Rinaldo Bellomo 4, 5, 6
Affiliation  

easibility trial, with a target of 60 adult patients undergoing major noncardiac surgery. We randomized patients to receive a peripheral low-concentration (10 µg/mL) norepinephrine or placebo (saline 0.9%) infusion. The study drug infusion was titrated to achieve a minimum systolic blood pressure target, preselected within 10% of baseline value and within the range limit 100 to 120 mm Hg during surgery and for up to 4 or 24 hours postoperatively. RESULTS: We achieved a high consent rate (84%), successful study drug administration throughout surgery (98% of patients) and absence of unblinding. There were no important study drug-related adverse events. The average intraoperative systolic blood pressure was 120 ± 12.6 mm Hg in the norepinephrine group and 115 ± 14.9 mm Hg in the placebo group. The mean difference between the intraoperative systolic blood pressure achieved less the preselected minimum systolic blood pressure target was 10.0 ± 12.7 mm Hg in the norepinephrine group and 2.9 ± 14.7 mm Hg in the placebo group; difference in means, 7.1 (95% confidence interval, 0.2–14.0) mm Hg. CONCLUSIONS: A future large trial evaluating the effectiveness and safety of peripheral administration of low-concentration norepinephrine during the perioperative period is feasible, and likely to achieve a minimum systolic blood pressure threshold....

中文翻译:

用于大手术的低浓度去甲肾上腺素输注:一项安全性和可行性初步随机对照试验

易用性试验,目标是 60 名接受非心脏大手术的成年患者。我们随机分配患者接受外周低浓度 (10 µg/mL) 去甲肾上腺素或安慰剂(盐水 0.9%)输注。滴定研究药物输注以达到最低收缩压目标,预选在基线值的 10% 范围内,在手术期间和术后 4 或 24 小时内限制在 100 至 120 mm Hg 范围内。结果:我们取得了很高的同意率(84%)、整个手术过程中成功的研究药物管理(98% 的患者)并且没有揭盲。没有重要的研究药物相关不良事件。去甲肾上腺素组的平均术中收缩压为 120 ± 12.6 mm Hg,安慰剂组为 115 ± 14.9 mm Hg。去甲肾上腺素组术中收缩压达到低于预先选择的最低收缩压目标值的平均差异为 10.0 ± 12.7 mm Hg,安慰剂组为 2.9 ± 14.7 mm Hg;均值差异,7.1(95% 置信区间,0.2–14.0)毫米汞柱。结论:未来的大型试验评估围手术期低浓度去甲肾上腺素外周给药的有效性和安全性是可行的,并且可能达到最低收缩压阈值。
更新日期:2022-01-18
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