Chewing gum to treat postoperative nausea and vomiting in female patients: a multicenter randomized trial.

IF 9.1 1区 医学 Q1 ANESTHESIOLOGY Anesthesiology Pub Date : 2024-10-30 DOI:10.1097/ALN.0000000000005283
Jai N Darvall, Anurika P De Silva, Britta von Ungern-Sternberg, David A Story, Andrew J Davidson, Megan L Allen, An Tran-Duy, Cindy Schultz-Ferguson, Vi Ha, Sabine Braat, Kate Leslie
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Abstract

Background: Postoperative nausea and vomiting (PONV) is common after general anesthesia, with consequences for patient outcomes, satisfaction with care and healthcare costs. Our aim was to compare a new treatment, chewing gum, with a widely-used intravenous agent, ondansetron, to treat PONV in female patients in the post anesthesia care unit (PACU).

Methods: We conducted a multicenter, randomized, controlled non-inferiority trial in 17 hospitals in Australia and New Zealand. Female patients aged ≥12 years undergoing volatile anesthetic-based general anesthesia for laparoscopic or breast surgery were enrolled. Protocolized anti-emetic prophylaxis was administered. Patients who developed PONV in the PACU were randomized to either 15 min of chewing gum or 4 mg of intravenous ondansetron. The primary outcome was cessation of nausea, retching or vomiting, with no recurrence nor rescue medication for 2 h after administration of the randomized intervention (i.e., complete response).

Results: Of 865 enrolled patients, 218 were randomized. In a per-protocol analysis, 50 of 105 (47.6%) ondansetron-treated patients compared with 31 of 103 (30.1%) chewing gum-treated patients achieved the primary outcome (absolute risk difference [95% confidence interval (CI)] -17.3 [-30.4 to -4.3] %), not reaching our prespecified non-inferiority limit. Time to complete response was longer for patients randomized to chewing gum (hazard ratio [95% CI] 0.53 [0.34, 0.83]), and they were more likely to receive antiemetics in the 24 h after surgery (absolute risk difference [95% CI] 14.07 [1.65, 26.49]).

Conclusions: Chewing gum cannot be recommended as an alternative to ondansetron for treatment of PONV in female patients administered antiemetic prophylaxis.

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用口香糖治疗女性患者术后恶心和呕吐:一项多中心随机试验。
背景:术后恶心和呕吐(PONV)是全身麻醉后的常见症状,会影响患者的预后、对护理的满意度和医疗成本。我们的目的是比较一种新疗法口香糖和一种广泛使用的静脉注射药物昂丹司琼,以治疗麻醉后护理病房(PACU)女性患者的 PONV:我们在澳大利亚和新西兰的 17 家医院开展了一项多中心随机对照非劣效性试验。年龄≥12岁、因腹腔镜手术或乳房手术而接受挥发性麻醉药全身麻醉的女性患者均被纳入试验范围。患者均按规定接受了止吐预防治疗。在 PACU 中出现 PONV 的患者被随机分配到咀嚼口香糖 15 分钟或静脉注射 4 毫克昂丹司琼的治疗方案中。主要结果是患者停止恶心、反胃或呕吐,且在接受随机干预后 2 小时内不再复发或服用抢救药物(即完全反应):在 865 名登记患者中,218 人接受了随机干预。在按方案进行的分析中,105 例昂丹司琼治疗患者中有 50 例(47.6%)与 103 例口香糖治疗患者中有 31 例(30.1%)相比达到了主要结果(绝对风险差异[95% 置信区间 (CI)]-17.3[-30.4 至 -4.3]%),未达到我们预先规定的非劣效性限值。随机接受口香糖治疗的患者完全应答时间更长(危险比[95% CI] 0.53 [0.34, 0.83]),术后24小时内接受止吐药的可能性更大(绝对风险差异[95% CI] 14.07 [1.65, 26.49]):结论:不建议用口香糖替代昂丹司琼治疗接受止吐药预防的女性患者的PONV。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Anesthesiology
Anesthesiology 医学-麻醉学
CiteScore
10.40
自引率
5.70%
发文量
542
审稿时长
3-6 weeks
期刊介绍: With its establishment in 1940, Anesthesiology has emerged as a prominent leader in the field of anesthesiology, encompassing perioperative, critical care, and pain medicine. As the esteemed journal of the American Society of Anesthesiologists, Anesthesiology operates independently with full editorial freedom. Its distinguished Editorial Board, comprising renowned professionals from across the globe, drives the advancement of the specialty by presenting innovative research through immediate open access to select articles and granting free access to all published articles after a six-month period. Furthermore, Anesthesiology actively promotes groundbreaking studies through an influential press release program. The journal's unwavering commitment lies in the dissemination of exemplary work that enhances clinical practice and revolutionizes the practice of medicine within our discipline.
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