Department of Anesthesia and Pain Management, Mount Sinai Hospital, University of Toronto, 600 University Avenue, Room 781, Toronto, ON, M5G 1X5, Canada.
Can J Anaesth. 2012 Aug;59(8):751-7. doi: 10.1007/s12630-012-9728-2. Epub 2012 Jun 21.
The primary objective of our study was to determine the minimum intravenous dose of carbetocin required to produce adequate uterine contraction in 95% of women (effective dose ED) undergoing elective Cesarean delivery (CD).
Eighty term pregnant women with low risk for postpartum hemorrhage (PPH) undergoing elective CD under spinal anesthesia were randomly allocated to receive carbetocin intravenously in doses of 80 μg, 90 μg, 100 μg, 110 μg, or 120 μg upon delivery. The consultant obstetrician evaluated the efficacy of the patient's uterine tone as satisfactory or unsatisfactory. In case of unsatisfactory uterine tone, additional uterotonics were administered as per routine institutional practice. Side effects were monitored during the study period. The main outcome measure was satisfactory uterine tone at two minutes after carbetocin administration.
Satisfactory uterine tone was obtained in 70 subjects (87%) within the dose range of 80-120 μg of carbetocin. It was not possible to calculate the ED(95) of carbetocin due to the even distribution of women with satisfactory uterine tone across all dose groups (P = 0.99). Similarly, the side effects were similar across all dose groups. There was a high overall incidence of hypotension (55%) following the administration of carbetocin.
In women at low risk for PPH undergoing elective CD, carbetocin doses of 80-120 μg are similarly effective. There is a high incidence of hypotension associated with carbetocin in these doses, and further studies with doses lower than 80 μg are warranted to assess the balance of efficacy and side effects. This trial was registered at www.clinicaltrials.gov (NCT01262742).
我们研究的主要目的是确定在接受择期剖宫产（CD）的低产后出血（PPH）风险的足月孕妇中，使 95%的女性获得足够子宫收缩所需的卡贝缩宫素的最小静脉剂量（有效剂量[ED]（95））。
80 名低 PPH 风险的足月孕妇在脊髓麻醉下接受择期 CD，随机分配在分娩时接受 80μg、90μg、100μg、110μg 或 120μg 的卡贝缩宫素静脉注射。顾问产科医生评估患者子宫收缩的效果是否满意。如果子宫收缩不满意，按照常规机构实践给予额外的宫缩剂。在研究期间监测副作用。主要观察指标是卡贝缩宫素给药后 2 分钟时的满意子宫收缩。
在 80-120μg 卡贝缩宫素剂量范围内，70 名（87%）女性获得满意的子宫收缩。由于所有剂量组均有满意子宫收缩的女性均匀分布（P=0.99），因此无法计算卡贝缩宫素的 ED（95）。同样，各剂量组的副作用相似。卡贝缩宫素给药后，总体低血压发生率较高（55%）。
在低 PPH 风险的择期 CD 妇女中，卡贝缩宫素剂量为 80-120μg 同样有效。这些剂量与卡贝缩宫素相关的低血压发生率较高，需要进一步研究剂量低于 80μg 的剂量，以评估疗效和副作用之间的平衡。本试验在 www.clinicaltrials.gov（NCT01262742）注册。
