BACKGROUND Spinal anesthesia is the preferred anesthetic technique for cesarean deliveries. Postoperative nausea and vomiting (PONV) and pruritus occur in up to 80% and 83% of patients, respectively, after cesarean delivery with intrathecal opioids. Ondansetron is the recommended medication for PONV prophylaxis, but palonosetron, a second-generation 5-HT3 receptor antagonist, has a higher receptor affinity and a longer half-life. However, studies on palonosetron use in cesarean deliveries are limited. This study aimed to determine whether palonosetron was more effective than ondansetron in preventing intrathecal morphine-induced PONV and pruritus in cesarean deliveries. METHODS Parturients who underwent cesarean delivery under spinal anesthesia were randomized into 3 groups: P (palonosetron 0.075 mg), O (ondansetron 4 mg), and N (normal saline). The study drug was intravenously administered after the umbilical cord was clamped. The primary outcome measures were the 48-hour incidence of PONV and pruritus. The secondary outcome measures were the PONV and pruritus scores at the postanesthesia care unit (PACU) and ward, rescue medications, satisfaction scores, and adverse events. Ordinal data were analyzed using the Kruskal-Wallis test. Continuous and categorical data were analyzed using a 1-way analysis of variance, Kruskal-Wallis test, and Pearson's χ2 test, respectively. A value of P < .05 was considered significant. Post hoc analysis pairwise comparisons with Bonferroni correction were also performed. RESULTS Overall, 300 parturients were enrolled, and 297 parturients completed the study. One patient in the P group and 2 in the O group were excluded because of conversion to general anesthesia after failed spinal anesthesia. The baseline patient characteristics were comparable between the groups. The PONV incidence rates in the P, O, and N groups were 26.3% (95% confidence interval [CI], 17.4-35.1), 34.7% (95% CI, 25.1-44.3), and 50.0% (95% CI, 40.0-59.9), respectively (P = .002). The incidence rates of pruritus in the P, O, and N groups were 69.7% (95% CI, 60.5-78.9), 76.5% (95% CI, 67.9-85.1), and 87.0% (95% CI, 80.3-93.7), respectively (P = .013). Pairwise comparisons revealed significantly lower incidences of PONV and pruritus in the P group than in the N group (P < .001 and P = .003, respectively). However, no significant differences were observed between the P and O groups or between the O and N groups. Additionally, the P group required significantly less nalbuphine rescue for pruritus than the N group (P = .004 and P = .005 for the PACU and ward, respectively). PONV rescue, satisfaction scores, and adverse events were not significantly different among the 3 groups. CONCLUSIONS Palonosetron effectively prevents intrathecal morphine-induced PONV and pruritus during cesarean delivery. However, the efficacy of palonosetron is not significantly different from that of ondansetron.

中文翻译：

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Palonosetron 与昂丹司琼治疗鞘内注射吗啡剖宫产恶心、呕吐和瘙痒的随机对照试验。


背景 脊髓麻醉是剖宫产的首选麻醉技术。术后恶心和呕吐 （PONV） 和瘙痒分别发生在高达 80% 和 83% 的患者在使用鞘内注射阿片类药物进行剖宫产后。昂丹司琼是 PONV 预防的推荐药物，但帕洛诺司琼是第二代 5-HT3 受体拮抗剂，具有更高的受体亲和力和更长的半衰期。然而，关于帕洛诺司琼在剖宫产中的应用的研究有限。本研究旨在确定帕洛诺司琼在预防剖宫产时鞘内吗啡诱导的 PONV 和瘙痒方面是否比昂丹司琼更有效。方法 将脊髓麻醉下行剖宫产的产妇随机分为 3 组： P （帕洛诺司琼 0.075 mg） 、O （昂丹司琼 4 mg） 和 N （生理盐水）。研究药物在夹住脐带后静脉给药。主要结局指标是 PONV 和瘙痒的 48 小时发生率。次要结局指标是麻醉后监护病房 （PACU） 和病房的 PONV 和瘙痒评分、抢救药物、满意度评分和不良事件。使用 Kruskal-Wallis 检验分析顺序数据。分别使用 1 因子方差分析、Kruskal-Wallis 检验和 Pearson χ2 检验分析连续数据和分类数据。P < .05 的值被认为是显著的。还进行了事后分析与 Bonferroni 校正的成对比较。结果 共纳入 300 例产妇，其中 297 例产妇完成了研究。P 组 1 例和 O 组 2 例患者因脊髓麻醉失败后转为全身麻醉而被排除在外。 两组之间的基线患者特征具有可比性。P 、 O 和 N 组的 PONV 发生率分别为 26.3% （95% 置信区间 [CI]，17.4-35.1 ）、34.7% （95% CI，25.1-44.3） 和 50.0% （95% CI，40.0-59.9） （P = .002）。P 、 O 和 N 组瘙痒发生率分别为 69.7% （95% CI，60.5-78.9） 、76.5% （95% CI，67.9-85.1） 和 87.0% （95% CI，80.3-93.7） （P = .013）。成对比较显示 P 组 PONV 和瘙痒的发生率显著低于 N 组 （分别为 P < .001 和 P = .003）。然而，P 组和 O 组之间或 O 和 N 组之间未观察到显著差异。此外，P 组对瘙痒症的纳布啡抢救需求显著低于 N 组 （PACU 和病房分别为 P = .004 和 P = .005）。3 组之间的 PONV 救援、满意度评分和不良事件差异无统计学意义。结论 Palonosetron 可有效预防剖宫产时鞘内吗啡诱导的 PONV 和瘙痒。然而，帕洛诺司琼的疗效与昂丹司琼的疗效没有显着差异。