Minimum effective dose of intrathecal hyperbaric bupivacaine for cesarean section with and without prophylactic norepinephrine infusion: Randomized triple-blinded trial

A. Tyagi, Monika Mathur, Rashmi Salhotra, R. Rautela
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Abstract

Vasopressor usage can affect the rostral spread of intrathecal drug and, hence, its requirement during cesarean delivery. Although a decreased spread is evidenced with phenylephrine, there is no data for norepinephrine usage. The present study aimed to evaluate the minimum effective dose of intrathecal hyperbaric bupivacaine for cesarean section with and without prophylactic norepinephrine infusion. Patients scheduled for elective cesarean section under combined spinal–epidural block were randomized to receive intravenous infusion of norepinephrine (0.05 μg/kg/min) or normal saline (placebo), initiated immediately after intrathecal injection. Postspinal hypotension in either group (systolic arterial pressure ≤0.8 baseline) was treated with norepinephrine 4 μg rescue. Dose of intrathecal hyperbaric bupivacaine (0.5%) was decided for individual patients using up-and-down sequential allocation method. Primary outcome measure was the minimum effective dose of intrathecal hyperbaric bupivacaine (0.5%) defined as ED50, while secondary observations included spinal block characteristics and neonatal outcomes. Demographic parameters were statistically similar between both groups (P > 0.05). ED50 of intrathecal hyperbaric bupivacaine was 7.8 mg (95% confidence interval [CI]: 6.7–8.8) and 7.4 mg (95% CI: 6.1–8.7) for normal saline and norepinephrine group respectively (P = 0.810). Block characteristics were similar between both groups as was neonatal APGAR score, but umbilical artery base excess was greater for norepinephrine versus normal saline group (−4.4 ± 3.6 vs. −6.5 ± 2.4, P = 0.038). Use of prophylactic norepinephrine (0.05 μg/kg/min) during cesarean delivery does not require adjustment of intrathecal hyperbaric bupivacaine.
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剖宫产术中使用或不使用预防性去甲肾上腺素输注鞘内高压布比卡因的最小有效剂量:三盲随机试验
使用血管抑制剂会影响鞘内药物的喙侧扩散,从而影响剖宫产时对药物的需求。虽然使用苯肾上腺素会减少药物的扩散,但目前还没有使用去甲肾上腺素的数据。本研究旨在评估在使用或不使用预防性去甲肾上腺素的情况下,用于剖宫产的鞘内高压布比卡因的最小有效剂量。 计划在脊柱-硬膜外联合阻滞下进行择期剖宫产的患者被随机分为两组,分别接受去甲肾上腺素(0.05 μg/kg/min)或生理盐水(安慰剂)的静脉注射,注射后立即开始鞘内注射。任何一组出现椎管后低血压(收缩压≤0.8 基线)时,均使用去甲肾上腺素 4 μg 进行抢救。鞘内高压布比卡因(0.5%)的剂量根据患者的具体情况采用上下顺序分配法决定。主要观察指标是鞘内高压布比卡因(0.5%)的最小有效剂量,即ED50,次要观察指标包括脊髓阻滞特征和新生儿预后。 两组的人口统计学参数相似(P > 0.05)。正常生理盐水组和去甲肾上腺素组的鞘内高压布比卡因 ED50 分别为 7.8 毫克(95% 置信区间 [CI]:6.7-8.8)和 7.4 毫克(95% 置信区间 [CI]:6.1-8.7)(P = 0.810)。两组阻滞特征相似,新生儿 APGAR 评分也相似,但去甲肾上腺素组的脐动脉基底超出量大于生理盐水组(-4.4 ± 3.6 vs. -6.5 ± 2.4,P = 0.038)。 在剖宫产过程中使用预防性去甲肾上腺素(0.05 μg/kg/min)无需调整鞘内高压布比卡因。
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