Jeon Younghoon, Kim Hyunjee, Kwak Kyung-Hwa
Department of Anesthesiology and Pain Medicine, Kyungpook National University Hospital, Jung gu, Daegu, Korea.
Curr Ther Res Clin Exp. 2010 Feb;71(1):78-88. doi: 10.1016/j.curtheres.2010.02.002.
Thyroidectomy is associated with a relatively high incidence of postoperative nausea and vomiting (PONV), ranging from 51% to 76%. Because these symptoms are distressing for patients, prophylactic medication to avoid or reduce PONV is recommended.
The aim of the present study was to compare the efficacy of ramosetron, dexamethasone, and a combination of ramosetron and dexamethasone in preventing PONV in Korean women undergoing thyroidectomy.
In this double-blind, randomized, controlled trial, consecutive adult female patients who were scheduled to undergo thyroidectomy under general anesthesia at the Kyungpook National University Hospital (Daegu, Korea) were randomly assigned to receive ramosetron 0.3 mg alone, dexamethasone 8 mg alone, or a combination of ramosetron 0.3 mg and dexamethasone 8 mg administered intravenously as a single dose immediately after induction of anesthesia. The primary end point of this study was the total PONV rate up to 24 hours postanesthesia. The secondary end points were the incidence of nausea, incidence of vomiting, severity of nausea (0 = no nausea to 10 = nausea as bad as it could be), use of rescue antiemetic drugs, and the occurrence of adverse events (AEs) determined through interview or spontaneous patient report for 24 hours postanesthesia.
A total of 198 female patients were approached for study inclusion, 18 of whom were excluded. Therefore, 180 Korean women (mean [SD] age, 46.5 [12.6] years; height, 159.8 [2.7] cm; weight, 53.2 [3.6] kg) were enrolled and completed the study. The total PONV rates up to 24 hours postanesthesia were 35%, 13%, and 10% in the dexamethasone, ramosetron, and combination groups, respectively. The PONV rate was significantly lower in the combination group than in the dexamethasone alone group (P = 0.006). The PONV rate was not significantly different in the combination group compared with the ramosetron alone group. The PONV rate in the dexamethasone alone group was significantly higher than that in the ramosetron alone group (P = 0.03). The severity of nausea (median [25th-75th percentiles], 0 [0-0] vs 0 [0-4]; P = 0.009) and rate of use of rescue antiemetic drugs (5% vs 27%; P = 0.006) were significantly lower in the combination group than in the dexamethasone alone group, whereas the severity of nausea (median [25th-75th percentiles], 0 [0-0] vs 0 [0-0]) and rate of use of rescue antiemetic drugs (5% vs 7%) were not significantly different between the combination and ramosetron alone groups. The severity of nausea (median [25th-75th percentiles], 0 [0-4] vs 0 [0-0]; P = 0.033) and the rate of use of rescue antiemetic drugs (27% vs 7%; P = 0.018) were significantly higher in the dexamethasone alone group than in the ramosetron alone group. The rates of AEs (headache: 15%, 20%, and 18%; dizziness: 18%, 22%, and 15%) were not significantly different in the dexamethasone alone, ramosetron alone, or combination groups, respectively.
The combination of ramosetron and dexamethasone was more effective in reducing PONV than was dexamethasone monotherapy. However, the combination did not show additional benefits compared with ramosetron alone in preventing PONV after thyroidectomy in these Korean women.
甲状腺切除术与术后恶心呕吐（PONV）的发生率相对较高相关，范围在51%至76%之间。由于这些症状会给患者带来痛苦，因此建议使用预防性药物来避免或减少PONV。
本研究的目的是比较雷莫司琼、地塞米松以及雷莫司琼与地塞米松联合用药在预防韩国接受甲状腺切除术女性患者PONV方面的疗效。
在这项双盲、随机、对照试验中，连续的成年女性患者计划在庆北国立大学医院（韩国大邱）接受全身麻醉下的甲状腺切除术，她们被随机分配单独接受0.3毫克雷莫司琼、单独接受8毫克地塞米松或在麻醉诱导后立即静脉单剂量给予0.3毫克雷莫司琼与8毫克地塞米松的联合用药。本研究的主要终点是麻醉后24小时内的总PONV发生率。次要终点包括恶心发生率、呕吐发生率、恶心严重程度（0 = 无恶心至10 = 恶心至极）、使用抢救性止吐药物情况以及通过访谈或患者自发报告确定的麻醉后24小时内不良事件（AE）的发生情况。
共有198名女性患者被纳入研究，其中18名被排除。因此，180名韩国女性（平均[标准差]年龄，46.5[12.6]岁；身高，159.8[2.7]厘米；体重，53.2[3.6]千克）被纳入并完成研究。地塞米松组、雷莫司琼组和联合用药组麻醉后24小时内总PONV发生率分别为35%、13%和10%。联合用药组的PONV发生率显著低于单独使用地塞米松组（P = 0.006）。联合用药组与单独使用雷莫司琼组相比，PONV发生率无显著差异。单独使用地塞米松组的PONV发生率显著高于单独使用雷莫司琼组（P = 0.03）。联合用药组的恶心严重程度（中位数[第25 - 75百分位数]，0[0 - 0]对0[0 - 4]；P = 0.009）和抢救性止吐药物使用率（5%对27%；P = 0.006）显著低于单独使用地塞米松组，而联合用药组与单独使用雷莫司琼组之间的恶心严重程度（中位数[第25 - 75百分位数]，0[0 - 0]对0[0 - 0]）和抢救性止吐药物使用率（5%对7%）无显著差异。单独使用地塞米松组的恶心严重程度（中位数[第25 - 75百分位数]，0[0 - 4]对0[0 - 0]；P = 0.033）和抢救性止吐药物使用率（27%对7%；P = 0.018）显著高于单独使用雷莫司琼组。地塞米松单独使用组、雷莫司琼单独使用组或联合用药组的AE发生率（头痛：15%、20%和18%；头晕：18%、22%和15%）分别无显著差异。
雷莫司琼与地塞米松联合用药在减少PONV方面比地塞米松单药治疗更有效。然而，在这些韩国女性甲状腺切除术后预防PONV方面，联合用药与单独使用雷莫司琼相比并未显示出额外的益处。
