Baytaş Volkan, Karadağ Erkoç Süheyla, Özçelik Menekşe, Gökmen Derya, Bermede Ahmet Onat, Selvi Can Özlem, Uysalel Asuman
Department of Anaesthesiology and ICM, School of Medicine, Ankara University, 06230 Ankara, Türkiye.
Department of Biostatistics, School of Medicine, Ankara University, 06290 Ankara, Türkiye.
J Clin Med. 2023 Oct 10;12(20):6437. doi: 10.3390/jcm12206437.
Norepinephrine has been recently introduced for prophylaxis against post-spinal hypotension during cesarean delivery; however, no data are available regarding its optimum dosing scheme. The primary objective of this study is to compare three different infusion and bolus dose combinations of norepinephrine for prophylaxis against post-spinal hypotension during cesarean delivery. This randomized, double-blind study was performed between February 2021 and May 2022. The study protocol was registered at Clinicaltrials.gov with the identification number NCT04701190. A total of 192 parturients were enrolled into this study. Patients were assigned to three groups-Zero-Bolus High-Infusion (Group ZBHI, 0 µg/0.1 µg kg min, = 61), Moderate-Bolus Moderate-Infusion (Group MBMI, 5 µg/0.075 µg kg min, = 61) and High-Bolus Low-Infusion (Group HBLI, 10 µg/0.05 µg kg min, = 61)-according to different combinations of norepinephrine infusion and bolus doses. All patients received spinal anesthesia with 10 mg hyperbaric bupivacaine plus 12.5 µg fentanyl. Immediately after cerebrospinal fluid was obtained, patients underwent a norepinephrine protocol corresponding to the randomized group. The primary outcome was the incidence of post-spinal hypotension. Secondary outcomes were post-delivery hypotension, frequency of post-spinal hypertension and bradycardia, and neonatal outcomes. The incidence of post-spinal hypotension was 11.7% in Group HBLI, 6.7% in Group ZBHI and 1.7% in Group MBMI ( = 0.1). The overall incidence of post-delivery hypotension in parturients was 41.1% ( = 0.797). The lowest frequency of post-spinal bradycardia (8.3%) and hypertension (11.7%) was seen in Group HBLI. The neonatal APGAR scores at 1st minute were higher in Group MBMI than in Group ZBHI (8.58 vs. 8.23, = 0.001). All three infusion and bolus dose combinations of norepinephrine effectively reduced the incidence of post-spinal hypotension. However, high-dose bolus (10 µg) followed by low-dose infusion (0.05 µg kg min) of norepinephrine can be preferred due to the reduced frequency of bradycardia and hypertension during cesarean delivery under spinal anesthesia.
去甲肾上腺素最近已被用于剖宫产术中预防脊髓麻醉后低血压；然而，关于其最佳给药方案尚无可用数据。本研究的主要目的是比较三种不同的去甲肾上腺素输注和推注剂量组合在剖宫产术中预防脊髓麻醉后低血压的效果。这项随机、双盲研究于2021年2月至2022年5月进行。该研究方案已在Clinicaltrials.gov上注册，识别号为NCT04701190。共有192名产妇纳入本研究。根据去甲肾上腺素输注和推注剂量的不同组合，患者被分为三组：零推注高输注组（ZBHI组，0µg/0.1µg·kg·min，n = 61）、中等推注中等输注组（MBMI组，5µg/0.075µg·kg·min，n = 61）和高推注低输注组（HBLI组，10µg/0.05µg·kg·min，n = 61）。所有患者均接受10mg重比重布比卡因加12.5µg芬太尼的脊髓麻醉。在获取脑脊液后，患者立即按照随机分组接受相应的去甲肾上腺素给药方案。主要结局是脊髓麻醉后低血压的发生率。次要结局包括产后低血压、脊髓麻醉后高血压和心动过缓的发生率以及新生儿结局。HBLI组脊髓麻醉后低血压的发生率为11.7%，ZBHI组为6.7%，MBMI组为1.7%（P = 0.1）。产妇产后低血压的总体发生率为41.1%（P = 0.797）。HBLI组脊髓麻醉后心动过缓（8.3%）和高血压（11.7%）的发生率最低。MBMI组新生儿第1分钟的阿氏评分高于ZBHI组（8.58对8.23，P = 0.001）。去甲肾上腺素的所有三种输注和推注剂量组合均有效降低了脊髓麻醉后低血压的发生率。然而，由于在脊髓麻醉下剖宫产术中心动过缓和高血压的发生率降低，去甲肾上腺素高剂量推注（10µg）后低剂量输注（0.05µg·kg·min）可能更受青睐。
