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临床试验/NCT02480088
NCT02480088已完成4 期

Comparison of Palonosetron and Ramosetron for Preventing Patient-controlled Analgesia Related Nausea and Vomiting Following Spine Surgery; Association With ABCB1 Polymorphism

Yonsei University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2014年9月22日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

patients receiving ramosetron for prophylaxis of postoperative nausea and vomiting

干预措施: Ramosetron (Drug)

palonosetron

Active Comparator

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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