Fujii Yoshitaka, Tanaka Hiroyoshi
Department of Anesthesiology, Toride Kyodo General Hospital, Toride City, Ibaraki, Japan.
Clin Ther. 2003 Dec;25(12):3135-42. doi: 10.1016/s0149-2918(03)90097-x.
Postoperative vomiting (POV) is an important adverse effect of anesthesia and surgery, and children undergoing tonsillectomy may be particularly at risk.
The aim of this study was to determine the effective dose of ramosetron, a 5-hydroxytryptamine type 3 receptor antagonist, for prophylaxis of severe POV (> or =2 episodes) in children undergoing general anesthesia for tonsillectomy.
Standard general anesthetic technique and postoperative analgesia were used in this prospective, randomized, double-blind, placebo-controlled, dose-ranging trial of pediatric patients. Patients who had experienced POV, had taken an antiemetic medication within 24 hours before surgery of had a history of motion sickness were excluded. Only patients aged 4 to 10 years were included, because of their ability to answer questions. Patients received a single administration of either i.v. placebo or i.v. ramosetron at 3, 6, or 12 microg/kg immediately after the end of surgery. During the first 48 hours after anesthesia, episodes of retching, vomiting, and adverse events were recorded by nursing staff blinded to treatment assignment.
Eighty children (20 in each group)--42 girls and 38 boys--were enrolled. There were no differences in patient demographic characteristics among the treatment groups. The rates of complete response (no vomiting, retching, or need for another antiemetic medication) from 0 to 24 hours after anesthesia were 35% (7/20) with ramosetron 3 microg/kg, 90% (18/20) with ramosetron 6 micro/kg, and 90% (18/20) with ramosetron 12 microg/kg compared with placebo (30% [620], P=NS, P=0.001, and P=0.001 vs placebo, respectively); the corresponding rates from 24 to 48 hours after anesthesia were 35% (7/20), 90% (18/20), and 95% (19/20) compared with placebo (35% [7/20]; P=NS, P=0.001, and P=0.001 vs placebo, respectively). No difference in antiemetic efficacy was observed between ramosetron 6 and 12 microg/kg. No clinically serious adverse events attributable to the study drug were observed in any group.
In the pediatric population studied, ramosetron 6 microg/kg was effective for the prevention of vomiting after tonsillectomy from 0 to 48 hours after anesthesia. Increasing the dose to 12 microg/kg did not appear to provide further benefit.
术后呕吐（POV）是麻醉和手术的一种重要不良反应，接受扁桃体切除术的儿童可能尤其面临风险。
本研究旨在确定5-羟色胺3型受体拮抗剂雷莫司琼预防接受扁桃体切除全身麻醉儿童严重POV（≥2次发作）的有效剂量。
在这项针对儿科患者的前瞻性、随机、双盲、安慰剂对照、剂量范围试验中采用标准全身麻醉技术和术后镇痛。排除有POV病史、术前24小时内服用过止吐药或有晕动病史的患者。仅纳入4至10岁的患者，因为他们有能力回答问题。患者在手术结束后立即静脉注射安慰剂或3、6或12μg/kg的静脉注射雷莫司琼。在麻醉后的前48小时内，由对治疗分配不知情的护理人员记录干呕、呕吐发作及不良事件。
共纳入80名儿童（每组20名），其中42名女孩和38名男孩。各治疗组患者的人口统计学特征无差异。麻醉后0至24小时完全缓解率（无呕吐、干呕或无需使用其他止吐药），雷莫司琼3μg/kg组为35%（7/20），雷莫司琼6μg/kg组为90%（18/20），雷莫司琼12μg/kg组为90%（18/20），而安慰剂组为30%（6/20）（与安慰剂相比，P=无统计学差异，P=0.001，P=0.001）；麻醉后24至48小时相应的缓解率分别为35%（7/20）、90%（18/20）和95%（19/20），而安慰剂组为35%（7/20）（与安慰剂相比，P=无统计学差异，P=0.001，P=0.001）。雷莫司琼6μg/kg和12μg/kg的止吐效果无差异。任何组均未观察到与研究药物有关的临床严重不良事件。
在所研究的儿科人群中，雷莫司琼6μg/kg对预防麻醉后0至48小时扁桃体切除术后呕吐有效。将剂量增加至12μg/kg似乎未带来进一步益处。
