Khalil S N, Kataria B, Pearson K, Conahan T, Kallar S, Zahl K, Gillies B, Campbell C, Brahen N, Gilmour I
Anesthesia Department, University of Texas Medical School, Houston 77030.
Anesth Analg. 1994 Nov;79(5):845-51. doi: 10.1213/00000539-199411000-00005.
Three doses of intravenous (i.v.) ondansetron, 1 mg, 4 mg, and 8 mg, were compared to placebo for their antiemetic effect and safety. The drugs or placebo were administered in a double-blind manner, prophylactically to 589 women undergoing elective outpatient surgical procedures under nitrous oxide opioid-based general endotracheal anesthesia. In the postanesthesia care unit, the number of emetic episodes, periodic assessments of nausea severity using an 11-point scale (0 = no nausea; 10 = worst nausea), vital signs, and adverse events were collected by an independent observer for 2 h. Upon discharge, identical information, with the exception of vital signs, was collected from the patients' diary and via phone call. One pre- and two poststudy blood specimens for hematology and chemistries were evaluated. During the initial 2 h, patients receiving any dose of ondansetron had significantly better complete response rates (no emesis) than those receiving placebo. Over the 24-h study period, patients who received either 4 mg or 8 mg ondansetron continued to have significantly greater complete response rates. Adverse events were minor, and ondansetron-treated patients had profiles similar to those of the placebo. Heart rate, blood pressure, respiratory rate, and laboratory safety variables were not different among the groups. Ondansetron did not prolong awakening time. This study indicates that ondansetron is a safe and effective prophylactic antiemetic for women who have outpatient surgery under nitrous oxide opioid-based general anesthesia.
将静脉注射（i.v.）的三剂昂丹司琼（剂量分别为1毫克、4毫克和8毫克）与安慰剂的止吐效果和安全性进行了比较。这些药物或安慰剂采用双盲方式，预防性地给予589名在基于氧化亚氮-阿片类药物的全身气管内麻醉下接受择期门诊手术的女性。在麻醉后护理单元，由一名独立观察者收集2小时内的呕吐发作次数、使用11分制（0 = 无恶心；10 = 最严重恶心）对恶心严重程度进行的定期评估、生命体征和不良事件。出院时，从患者日记和通过电话收集除生命体征外的相同信息。对一份研究前和两份研究后的血液样本进行血液学和化学评估。在最初的2小时内，接受任何剂量昂丹司琼的患者的完全缓解率（无呕吐）明显优于接受安慰剂的患者。在24小时的研究期间，接受4毫克或8毫克昂丹司琼的患者的完全缓解率仍然明显更高。不良事件轻微，接受昂丹司琼治疗的患者的情况与接受安慰剂的患者相似。各组之间的心率、血压、呼吸频率和实验室安全变量没有差异。昂丹司琼没有延长苏醒时间。这项研究表明，昂丹司琼对于在基于氧化亚氮-阿片类药物的全身麻醉下进行门诊手术的女性是一种安全有效的预防性止吐药。
