Primary, secondary, and other outcomes.

BackgroundThe aim of this study was to evaluate the impact of intravenous palonosetron compared to ondansetron on hypotension induced by spinal anesthesia in women undergoing cesarean section.MethodsFifty-four women scheduled for elective cesarean section were, randomly allocated to ondansetron group (n = 27) or palonosetron group (n = 27). Ten minutes prior to the administration of spinal anesthesia, participants received an intravenous injection of either ondansetron or palonosetron. A prophylactic phenylephrine infusion was initiated immediately following the intrathecal administration of bupivacaine and fentanyl. The infusion rate was titrated to maintain adequate blood pressure until the time of fetal delivery. The primary outcome was total dose of phenylephrine administered. The secondary outcomes were nausea or vomiting, the need for rescue antiemetics, hypotension, bradycardia, and shivering. Complete response rate, defined as the absence of postoperative nausea and vomiting and no need for additional antiemetics, were assessed for up to 24 hours post-surgery.ResultsNo significant differences were observed in the total dose of phenylephrine used between the ondansetron and palonosetron groups (387.5 μg [interquartile range, 291.3–507.8 μg versus 428.0 μg [interquartile range, 305.0–507.0 μg], P = 0.42). Complete response rates also showed no significant differences between the groups both within two hours post-spinal anesthesia (88.9% in the ondansetron group versus 100% in the palonosetron group; P = 0.24) and at 24 hours post-surgery (81.5% in the ondansetron group versus 88.8% in the palonosetron group; P = 0.7). In addition, there was no difference in other secondary outcomes.ConclusionProphylactic administration of palonosetron did not demonstrate a superior effect over ondansetron in mitigating hemodynamic changes or reducing phenylephrine requirements in patients undergoing spinal anesthesia with bupivacaine and fentanyl for cesarean section.研究背景：本研究旨在评估静脉应用帕洛诺司琼（palonosetron）对比昂丹司琼（ondansetron），对剖宫产术（cesarean section）产妇脊髓麻醉（spinal anesthesia）诱导低血压的影响。研究方法：本研究共纳入54例拟行择期剖宫产术的产妇，采用随机分配原则分为昂丹司琼组（n=27）与帕洛诺司琼组（n=27）。于脊髓麻醉给药前10分钟，两组产妇分别静脉注射昂丹司琼或帕洛诺司琼。在鞘内注射（intrathecal administration）布比卡因（bupivacaine）与芬太尼（fentanyl）后，即刻启动预防性去氧肾上腺素（phenylephrine）输注，并根据血压情况调整输注速率，以维持血压稳定直至胎儿娩出。本研究的主要结局为去氧肾上腺素的总给药剂量；次要结局包括恶心呕吐、急救止吐药物使用需求、低血压、心动过缓与寒战。本研究同时评估了术后24小时内的完全应答率，其定义为无术后恶心呕吐且无需额外止吐治疗。研究结果：昂丹司琼组与帕洛诺司琼组的去氧肾上腺素总给药剂量无显著统计学差异（387.5μg [四分位间距（interquartile range）, 291.3–507.8μg] 对比428.0μg [四分位间距, 305.0–507.0μg]，P=0.42）。脊髓麻醉后2小时内，两组的完全应答率亦无显著统计学差异（昂丹司琼组为88.9%，帕洛诺司琼组为100%；P=0.24）；术后24小时时，两组完全应答率同样无显著差异（昂丹司琼组81.5%，帕洛诺司琼组88.8%；P=0.7）。此外，其余次要结局指标亦无组间差异。研究结论：对于接受布比卡因联合芬太尼脊髓麻醉行剖宫产术的产妇，预防性应用帕洛诺司琼在改善血流动力学变化或减少去氧肾上腺素给药需求方面，并未展现出优于昂丹司琼的效果。