Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, Melbourne, Victoria, Australia
Royal Melbourne Hospital Clinical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.
Br J Anaesth. 2017 Jan;118(1):83-89. doi: 10.1093/bja/aew375.
A novel treatment, chewing gum, may be non-inferior to ondansetron in inhibiting postoperative nausea and vomiting (PONV) in female patients after laparoscopic or breast surgery. In this pilot study, we tested the feasibility of a large randomized controlled trial.
We randomized 94 female patients undergoing laparoscopic or breast surgery to ondansetron 4 mg i.v. or chewing gum if PONV was experienced in the postanaesthesia care unit (PACU). The primary outcome was full resolution of PONV, with non-inferiority defined as a difference between groups of <15% in a per protocol analysis. Secondary outcomes were PACU stay duration, anti-emetic rescue use, and acceptability of anti-emetic treatment. The feasibility of implementing the protocol in a larger trial was assessed.
Postoperative nausea and vomiting in the PACU occurred in 13 (28%) ondansetron patients and 15 (31%) chewing gum patients (P=0.75). Three chewing gum patients could not chew gum when they developed PONV. On a per protocol basis, full resolution of PONV occurred in five of 13 (39%) ondansetron vs nine of 12 (75%) chewing gum patients [risk difference 37% (6.3-67%), P=0.07]. There was no difference in secondary outcomes between groups. Recruitment was satisfactory, the protocol was acceptable to anaesthetists and nurses, and data collection was complete.
In this pilot trial, chewing gum was not inferior to ondansetron for treatment of PONV after general anaesthesia for laparoscopic or breast surgery in female patients. Our findings demonstrate the feasibility of a larger, multicentred randomized controlled trial to investigate this novel therapy.
Australian New Zealand Clinical Trials Registry: ACTRN12615001327572.
一种新型治疗方法，即咀嚼口香糖，在抑制女性腹腔镜或乳房手术后患者的术后恶心和呕吐（PONV）方面可能不亚于昂丹司琼。在这项初步研究中，我们测试了一项大型随机对照试验的可行性。
我们将 94 名接受腹腔镜或乳房手术的女性患者随机分为昂丹司琼 4 毫克静脉注射或在麻醉后护理单元（PACU）出现 PONV 时使用咀嚼口香糖。主要结局是 PONV 完全缓解，非劣效性定义为意向治疗分析中两组之间的差异<15%。次要结局是 PACU 停留时间、止吐药解救使用和止吐治疗的可接受性。评估了在更大规模试验中实施该方案的可行性。
在 PACU 中发生术后恶心的患者有 13 名（28%）昂丹司琼组和 15 名（31%）咀嚼口香糖组（P=0.75）。有 3 名咀嚼口香糖的患者在出现 PONV 时无法咀嚼口香糖。在按意向治疗方案分析中，13 名（39%）昂丹司琼组中有 5 名患者 PONV 完全缓解，而 12 名（75%）咀嚼口香糖组中有 9 名患者[风险差异 37%（6.3-67%），P=0.07]。两组之间的次要结局无差异。招募情况令人满意，该方案得到麻醉师和护士的认可，数据收集完整。
在这项初步试验中，在女性腹腔镜或乳房手术后全麻患者中，咀嚼口香糖在治疗 PONV 方面并不逊于昂丹司琼。我们的研究结果表明，进行更大规模、多中心随机对照试验以研究这种新疗法具有可行性。
澳大利亚新西兰临床试验注册中心：ACTRN12615001327572。
