From the Department of Research and Development, Division of Emergencies and Critical Care, Oslo University Hospital (MEB, LAR), the Institute of Clinical Medicine, Faculty of Medicine, University of Oslo (MEB, OK, LAR), the Oslo Centre for Biostatistics and Epidemiology, Research Support Services (MWF), the Department of Cardiology (OGS, LA), the Department of Medical Biochemistry, Oslo University Hospital, Oslo, Norway (OK), and the Vestre Viken Hospital, Department of Clinical Biochemistry, Drammen, Norway (JN).
Eur J Anaesthesiol. 2022 Dec 1;39(12):928-938. doi: 10.1097/EJA.0000000000001763. Epub 2022 Oct 17.
Oxytocin can stimulate release of myocardial biomarkers troponin I and T, prolong QTc and induce ST-depression.
To explore cardiac changes after either intravenous carbetocin or oxytocin.
Exploratory phase 4 randomised controlled trial.
Obstetrics units of Oslo University Hospital, Norway between September 2015 and May 2018.
Forty healthy, singleton pregnant women aged 18 to 50 years at gestational age at least 36 weeks with a planned caesarean delivery.
Participants were randomised to receive either oxytocin 2.5 IU or carbetocin 100 μg immediately after delivery.
The primary endpoint was the assessment of troponin I within 48 h of study drug administration. Troponin I and T, and creatine kinase myocardial band assessments were measured before spinal anaesthesia (baseline), and again at 4, 10 and 24 h after delivery. QTc, ST-depression and relative increase in heart rate were recorded from start of study drug administration to 10 min after delivery. All adverse events were monitored.
Compared with the carbetocin group, higher troponin I levels were observed in the oxytocin group at 4 h and 10 h after delivery. For both treatment groups, an increase from baseline in troponin I and T was most pronounced at 10 h after delivery, and it had begun to decline by 24 h. QTc increased with time after administration of both study drugs, with a mean maximum increase of 10.4 ms observed at 9 min (P < 0.001). No statistical differences were observed in QTc ( P = 0.13) or ST-depression ( P = 0.11) between the treatment groups.
Oxytocin 2.5 IU and carbetocin 100 μg caused a similar increase in QTc. The trial was underpowered with regards to ST-depression and the release of myocardial biomarkers and these warrant further investigation. Data from this trial will inform a larger phase 4 trial to determine potential drug differences in troponin release.
ClinicalTrials.gov Identifier: NCT02528136.
催产素可刺激肌钙蛋白 I 和 T 的释放，延长 QTc 并引起 ST 压低。
探讨静脉注射卡贝缩宫素或催产素后的心脏变化。
探索性 4 随机对照试验。
挪威奥斯陆大学医院妇产科单位，2015 年 9 月至 2018 年 5 月。
40 名年龄在 18 至 50 岁之间的健康、单胎妊娠妇女，妊娠至少 36 周，计划行剖宫产。
参与者随机接受分娩后立即给予催产素 2.5IU 或卡贝缩宫素 100μg。
主要终点是研究药物给药后 48 小时内肌钙蛋白 I 的评估。肌钙蛋白 I 和 T 以及肌酸激酶心肌带的评估在脊髓麻醉前（基线）进行，然后在分娩后 4、10 和 24 小时再次进行。从开始给予研究药物到分娩后 10 分钟，记录 QTc、ST 压低和心率的相对增加。监测所有不良事件。
与卡贝缩宫素组相比，催产素组在分娩后 4 小时和 10 小时的肌钙蛋白 I 水平更高。对于两个治疗组，肌钙蛋白 I 和 T 从基线的增加在分娩后 10 小时最为明显，并且在 24 小时后开始下降。给予两种研究药物后 QTc 随时间增加，在 9 分钟时观察到平均最大增加 10.4ms（P<0.001）。在 QTc（P=0.13）或 ST 压低（P=0.11）方面，两组之间无统计学差异。
催产素 2.5IU 和卡贝缩宫素 100μg 引起 QTc 相似增加。该试验在 ST 压低和心肌生物标志物释放方面的效力不足，需要进一步研究。本试验的数据将为确定肌钙蛋白释放方面的潜在药物差异提供更大的 4 期试验。
ClinicalTrials.gov 标识符：NCT02528136。
