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PURPOSE: This study was conducted to evaluate the efficacy and safety of azasetron compared to ondansetron in the prevention of delayed chemotherapy-induced nausea and vomiting. MATERIALS AND METHODS: This study was a multi-center, prospective, randomized, double-dummy, double-blind and parallel-group trial involving 12 institutions in Korea between May 2005 and December 2005. A total of 265 patients with moderately and highly emetogenic chemotherapy were included and randomly assigned to either the azasetron or ondansetron group. All patients received azasetron (10 mg intravenously) and dexamethasone (20 mg intravenously) on day 1 and dexamethasone (4 mg orally every 12 hours) on days 2-4. The azasetron group received azasetron (10 mg orally) with placebo of ondansetron (orally every 12 hours), and the ondansetron group received ondansetron (8 mg orally every 12 hours) with placebo of azasetron (orally) on days 2-6. RESULTS: Over days 2-6, the effective ratio of complete response in the azasetron and ondansetron groups was 45% and 54.5%, respectively (95% confidence interval, -21.4 to 2.5%). Thus, the non-inferiority of azasetron compared with ondansetron in delayed chemotherapy-induced nausea and vomiting was not proven in the present study. All treatments were well tolerated and no unexpected drug-related adverse events were reported. The most common adverse events related to the treatment were constipation and hiccups, and there were no differences in the overall incidence of adverse events. CONCLUSION: In the present study, azasetron showed inferiority in the control of delayed chemotherapy-induced nausea and vomiting compared with ondansetron whereas safety profiles were similar between the two groups.
Subject(s)
Humans , Antineoplastic Agents , Constipation , Dexamethasone , Drug Therapy , Hiccup , Incidence , Korea , Nausea , Ondansetron , Prospective Studies , Serotonin Antagonists , VomitingABSTRACT
PURPOSE: We compared the prophylactic effects of intravenously administered azasetron (10 mg) and ondansetron (8 mg) on postoperative nausea and vomiting (PONV) in patients undergoing gynecological laparoscopic surgery under general anesthesia. MATERIALS AND METHODS: We studied 98 ASA physical status I or II 20-65 years old, female patients, in this prospective, randomized, double blind study. Patients were randomly divided into two groups and received ondansetron 8 mg (group O) or azasetron 10 mg (group A) 5 min before the end of surgery. The incidence of PONV, Visual Analogue Scale (VAS) for pain, need for rescue antiemetic and analgesics, and adverse effects were checked at 1, 6, 12, 24, and 48 h postoperatively. RESULTS: The overall incidence of PONV was 65% in group O and 49% in group A. The incidence of PONV was significantly higher in group O than in group A at 12-24 h postoperatively (nausea; 24% vs. 45%, p = 0.035, vomiting; 2% vs. 18%, p = 0.008), but there were no significant differences at 0-1, 1-6, 6-12 or 24-48 h. CONCLUSION: In conclusion, azasetron (10 mg) produced same incidence of PONV as ondansetron (8 mg) in patients undergoing general anesthesia for gynecological laparoscopic surgery. Azasetron was more effective, in the intermediate post-operative period, between 12 and 24 h.
Subject(s)
Adult , Aged , Female , Humans , Middle Aged , Young Adult , Bridged Bicyclo Compounds, Heterocyclic/therapeutic use , Gynecologic Surgical Procedures/adverse effects , Ondansetron/therapeutic use , Oxazines/therapeutic use , Postoperative Nausea and Vomiting/prevention & control , Serotonin Antagonists/therapeutic use , Treatment OutcomeABSTRACT
Objective To observe the effectiveness of dexamethasone combined with azasetron for the prevention of postoperative nausea and vomiting(PONV) in patients after laparoscopic cholecystectomy(LC).Methods A total of 150 ASA(Ⅰ~Ⅱ) patients undergoing an elective LC were randomly divided into three groups with 50 patients in each group: Group D+A was given intravenous dexamethasone 5mg and azasetron 10mg(2ml) at the end of surgery,Group A received intravenous azasetron 10mg(2ml) at the end of surgery,and Group C received normal saline(NS) 2 ml as the control.Episodes of nausea and vomiting were recorded for 24 h following the surgery.Results The incidence of nausea was 4% in the Group D+A(2/50),which was significantly lower than in the Group A(16%,8/50) and the Group C(34%,17/50)(?~2=4.00 and 14.62;P=0.046 and 0.000).The incidence of vomiting was 2% in the Group D+A(1/50),which was significantly lower than in the Group A (14%,(7/50)) and the Group C(32%,16/50)(?~2=4.89 and 15.95;P=0.027 and 0.000).The incidences of nausea and vomiting were significantly lower in the Group A than in the Group C(?~2=4.32 and 4.57;P=0.038 and 0.033).Conclusions Use of a low dose of dexamethasone in combination with azasetron is more effective than azasetron prophylaxis alone for a successful control of PONV after LC.
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AIM:To evaluate the prophylactic effect of azasetron in different juncture injection on postoperative nausea and vomiting(PONV)during patients controlled intravenous ananlgesia(PCIA).METHODS:One hundred and twenty patients,scheduled for selective abdominal operations,were randomly divided into four groups:patients received an preoperative intravenous injection of 10 mg azasetron(Group A,n=30),patients received an intravenous injection of 10 mg azasetron during abdominal cavity(Group B,n=30),patients received an intravenous injection of 10 mg azasetron when the operation were finished(Group C,n=30),patients with no azasetron as control(Group D,n=30).The incidence rate and score of PONV,the visual analogue scales(VAS)and Ramsay scores were recorded at 4,8,12,24,48 h postoperatively.RESULTS:There was significant difference between the postoperative VAS during 12 to 48 h and that of 4 h postoperatively(?0.05).CONCLUSION:A preoperative intravenous injection of 10 mg azasetron can be used effectively to prevent PONV during PCIA.
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Purpose: To evaluate the antiemetic effect of azasetron hydrochloride in patients with liver neoplasm after transcatheter arterial chemoembolization. Methods: 62 patients (33 with primary hepatocellular carcinoma and 29 with hepatic metastasis), who underwent transcatheter arterial chemoembolization( TACE) therapy 78 times in all, were allocated into the azasetron group( administration of azasetron hydrochloride) and the control group( administration of metoclopramide) randomly. The inhibitory effects on nausea and vomiting were observed in the two groups respectively. Results: The antiemetic CR ratio and the response rate( CR + PR) in the azasetron group was 81.0% and 99. 7%, respectively. These results were statistically higher than those in the control group( P