Fujii Y, Saitoh Y, Tanaka H, Toyooka H
Department of Anesthesiology, University of Tsukuba Institute of Clinical Medicine, Tsukuba City, Japan.
Anesth Analg. 2000 Feb;90(2):472-5. doi: 10.1097/00000539-200002000-00043.
In a prospective, randomized, double-blinded, placebo-controlled trial, we evaluated the efficacy of ramosetron at three different doses (0.15, 0.3, and 0.6 mg) for the prevention of postoperative nausea and vomiting (PONV) after gynecological surgery. One hundred twenty women, ASA physical status I or II, aged 21-63 yr, received IV either placebo or ramosetron 0.15, 0.3, or 0.6 mg (n = 30 of each) at the completion of surgery. A standard general anesthetic technique and postoperative analgesia were used. A complete response, defined as no PONV and no need for another rescue antiemetic, during 0-3 h after anesthesia occurred in 40%, 47%, 87%, and 90% of patients who had received placebo and ramosetron 0.15, 0.3, and 0.6 mg, respectively. Corresponding results during 3-24 h after anesthesia were 43%, 50%, 87%, and 90%, and 24-48 h after anesthesia were 50%, 53%, 90%, and 93% (P < 0.05). Patients who had received ramosetron 0.3 or 0.6 mg were satisfied compared with those who had received placebo (P < 0.05). There were no serious clinical adverse events caused by the study drug in any of the groups. In conclusion, ramosetron 0.3 mg is an effective antiemetic for preventing PONV during 0-48 h after anesthesia in female patients undergoing gynecological surgery. Increasing the dose to 0.6 mg provided no further benefit.
This randomized, double-blinded, placebo-controlled trial in 120 women found the effective dose of ramosetron for preventing postoperative nausea and vomiting after gynecological surgery to be 0.3 mg.
在一项前瞻性、随机、双盲、安慰剂对照试验中，我们评估了三种不同剂量（0.15、0.3和0.6毫克）的雷莫司琼预防妇科手术后恶心和呕吐（PONV）的疗效。120名年龄在21 - 63岁、美国麻醉医师协会（ASA）身体状况为I或II级的女性，在手术结束时静脉注射安慰剂或0.15、0.3或0.6毫克雷莫司琼（每组n = 30）。采用标准的全身麻醉技术和术后镇痛。在麻醉后0 - 3小时内，完全缓解（定义为无PONV且无需再次使用抢救性止吐药）的患者比例分别为：接受安慰剂的患者为40%，接受0.15毫克雷莫司琼的患者为47%，接受0.3毫克雷莫司琼的患者为87%，接受0.6毫克雷莫司琼的患者为90%。麻醉后3 - 24小时的相应结果分别为43%、50%、87%和90%，麻醉后24 - 48小时的相应结果分别为50%、53%、90%和93%（P < 0.05）。与接受安慰剂的患者相比，接受0.3或好0.6毫克雷莫司琼的患者满意度更高（P < 0.05）。任何一组中均未出现由研究药物引起的严重临床不良事件。总之，0.3毫克雷莫司琼是预防妇科手术女性患者麻醉后0 - 48小时内PONV的有效止吐药。将剂量增加至0.6毫克未带来进一步益处。
这项针对120名女性的随机、双盲、安慰剂对照试验发现，预防妇科手术后恶心和呕吐的雷莫司琼有效剂量为0.3毫克。
