Comparison of Palonosetron and Ramosetron for Preventing Patient-controlled Analgesia Related Nausea and Vomiting Following Spine Surgery; Association With ABCB1 Polymorphism
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- number of postoperative nausea and vomiting incidence
研究概览
简要总结
Opioid-based intravenous patient-controlled analgesia (IV-PCA) offers excellent pain control, however, its use inevitably increases the incidence of postoperative nausea and vomiting (PONV). Ramosetron and palonosetron are commonly used 5-HT3 antagonists for the prevention and treatment of PONV. It is not clear which one has superior antiemetic efficacy for the prevention of PONV in patients using opioid-based IV-PCA. The antiemetic efficacy of 5HT3 antagonists may be influenced by polymorphism of ABCB1, a drug-transporter gene. This study evaluates relative antiemetic efficacy of ramosetron and palonosetron in patients using IV-PCA after spinal surgery and impact of ABCB1 polymorphism on the antiemetic efficacy of the ramosetron and palonosetron. The incidence and intensity of PONV during postoperative 48 h will be assessed. ABCB1 polymorphisms 3435C>T and 2677G>T/A will be evaluated in all patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 20-85 yr
- •undergoing spine surgery
排除标准
- •Taking steroids or opioids preoperatively
- •GI motility disorder
- •Uncontrolled diabetes
- •Severe renal or hepatic disease
- •Transfer to ICU postoperatively
- •Obesity (BMI>35 kg/m2)
- •Use of antiemetic agent within 24 h preoperatively
- •Pregnancy
- •Psychiatric disease
- •Drug or alcohol abuser
- •Malignancy
研究组 & 干预措施
ramosetron
patients receiving ramosetron for prophylaxis of postoperative nausea and vomiting
干预措施: Ramosetron (Drug)
palonosetron
patients receiving palonosetron for prophylaxis of postoperative nausea and vomiting
干预措施: Palonosetron (Drug)
结局指标
主要结局
number of postoperative nausea and vomiting incidence
时间窗: during postoperative 48h
次要结局
未报告次要终点
