Therapeutic Efficacy of Ramosetron for Treatment of Established PONV After Laparoscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 主要终点
- ratio of complete response
研究概览
简要总结
Patients who had at least two risk factors of PONV (Postoperative nausea and vomiting) and underwent laparoscopic surgeries under general anesthesia were assessed for eligibility. Patients who developed PONV within the first 2 hours after anesthesia received intravenously, in a randomized double-blind manner, ondansetron 4 mg or ramosetron 0.3 mg. Patients were then observed for 24 hours after drug administration. The incidence of nausea and vomiting, severity of nausea, requirements for rescue antiemetic and adverse effects at 0-2 and 2-24 hours after drug administration were evaluated. The primary endpoint was the rate of patients exhibiting complete response, defined as no emesis and no further rescue antiemetic medication for 24 hours after drug administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 19-65 years
- •patients undergoing elective laparoscopic surgery under inhalational anesthesia
- •duration of surgery between 30 min to 4 h
- •ASA (American Society of Anesthesiologists) physical status I or II, and patients who had at least two of these risk factors
- •female gender, history of motion sickness (MS) or PONV, nonsmoking, and the use of postoperative opioids.
排除标准
- •patients with history of being allergic to 5-HT3 receptor antagonist
- •patients with history of anticancer chemotherapy
- •chronic opioids use, alcohol abuse, or drug abuse
- •patients who took antiemetic medication within 24 h before surgery, steroids within 24 h before surgery or 24 h after surgery
- •presence of renal (serum Cr > 1.6 mg/dl)
- •hepatic(liver enzymes more than 2 times normal value) insufficiency
- •patients converted to open laparotomy
- •patient who are pregnant or breast-feeding
- •patient with borderline QTc(corrected QT interval) prolongation (> 430 ms for male, >450 ms for female)
- •patient not able to understand the scoring of pain or express the degree of PONV.
研究组 & 干预措施
Ondansetron group
干预措施: Ondansetron (Drug)
Ramosetron group
干预措施: Ramosetron (Drug)
结局指标
主要结局
ratio of complete response
时间窗: 24 hours after administration of study drug
complete response is defined as no retching or vomiting and no secondary rescue antiemetic administration
次要结局
- incidence of nausea and vomiting(24 hours after administration of study drug)