预防性去甲肾上腺素联合 6%羟乙基淀粉（130/0.4）共同负荷输注预防剖宫产术后椎管内麻醉低血压：一项随机、对照、剂量探索试验。
Prophylactic norepinephrine combined with 6% hydroxyethyl starch (130/0.4) co-load infusion for preventing postspinal anesthesia hypotension during cesarean section: a randomized, controlled, dose-finding trial.
机构信息
Department of Anesthesiology and Perioperative Medicine, General Hospital of Ningxia Medical University, 804S Shengli Street, Yinchuan, 750004, Ningxia, China.
Department of Anaesthesiology, The Fifth People's Hospital of Huaian, Huaian, Jiangsu, China.
出版信息
Daru. 2024 Jun;32(1):1-9. doi: 10.1007/s40199-023-00479-7. Epub 2023 Oct 9.
PURPOSE
Colloid and/or co-load may be more effective than crystalloid for preventing postspinal anesthesia hypotension. We tested five different prophylactic norepinephrine dosages combined with colloid co-load infusion in patients receiving cesarean section and spinal anesthesia.
METHODS
Patients were randomly allocated to receive different prophylactic norepinephrine dosages (0 [NE 0 group], 0.025 [NE 25 group], 0.05 [NE 50 group], 0.075 [NE 75 group], or 0.1 [NE 100 group] µg/kg/min) combined with 500 mL 6% hydroxyethyl starch (130/0.4) immediately following spinal anesthesia (n = 35 per group). The primary endpoint was the incidence of postspinal anesthesia hypotension (systolic blood pressure [SBP] < 80% of baseline). Secondary endpoints included severe hypotension, bradycardia, nausea or vomiting, hypertension, SBP stability control versus baseline, the 50% (effective dose, ED50) and 90% (ED90) dose effective for preventing postspinal anesthesia hypotension, Apgar scores, and umbilical cord blood gases.
RESULTS
The incidence of postspinal anesthesia hypotension was 48.6%, 31.3%, 17.1%, 14.3%, and 5.7% in the respective groups. As the prophylactic norepinephrine dosage increased, the incidence of postspinal anesthesia hypotension declined (p < 0.001), and SBP remained stable relative to baseline (median performance error [MDPE], p < 0.001; median absolute performance error [MDAPE], p = 0.001). The ED50 and ED90 values were -0.006 (95% CI -0.046-0.013) and 0.081 (95% CI 0.063-0.119) µg/kg/min. Other endpoints were comparable across the groups.
CONCLUSION
An initial prophylactic norepinephrine dosage of 0.05 µg/kg/min combined with 500 mL 6% hydroxyethyl starch (130/0.4) co-load infusion was optimal for preventing postspinal anesthesia hypotension during cesarean section.
TRIAL REGISTRATION
NCT05133817, registration date: 12 Nov, 2021.
目的
胶体和/或共负荷可能比晶体更能预防椎管内麻醉后低血压。我们测试了五种不同的预防用去甲肾上腺素剂量与胶体共负荷输注联合应用于接受剖宫产和脊髓麻醉的患者。
方法
患者随机分为接受不同预防用去甲肾上腺素剂量（0 [NE 0 组]、0.025 [NE 25 组]、0.05 [NE 50 组]、0.075 [NE 75 组]或 0.1 [NE 100 组]µg/kg/min）联合脊髓麻醉后立即输注 500mL 6%羟乙基淀粉（130/0.4）（每组 35 例）。主要终点是椎管内麻醉后低血压的发生率（收缩压[SBP]＜基线的 80%）。次要终点包括严重低血压、心动过缓、恶心或呕吐、高血压、SBP 与基线相比的稳定性控制、预防椎管内麻醉后低血压的 50%（有效剂量，ED50）和 90%（ED90）剂量、阿普加评分和脐血血气。
结果
各组椎管内麻醉后低血压的发生率分别为 48.6%、31.3%、17.1%、14.3%和 5.7%。随着预防用去甲肾上腺素剂量的增加，椎管内麻醉后低血压的发生率下降（p<0.001），SBP 相对于基线保持稳定（中位数性能误差[MDPE]，p<0.001；中位数绝对性能误差[MDAPE]，p=0.001）。ED50 和 ED90 值分别为-0.006（95%CI-0.046-0.013）和 0.081（95%CI 0.063-0.119）µg/kg/min。其他终点在各组之间相似。
结论
剖宫产术中，初始预防用去甲肾上腺素剂量 0.05µg/kg/min 联合 500mL 6%羟乙基淀粉（130/0.4）共负荷输注预防椎管内麻醉后低血压效果最佳。
试验注册
NCT05133817，注册日期：2021 年 11 月 12 日。
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