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临床试验/NCT01952626
NCT01952626已完成不适用

Prevention of Intrathecal Morphine Induced Pruritus: Comparison of Ondansetron and Palonosetron

Kyungpook National University Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2013年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Incidence of pruritus

研究概览

简要总结

Intrathecal administration of morphine is often used for control of postoperative pain. However, pruritus is one of the most common side effects of intrathecal morphine . Specific serotonin receptor antagonists could be an effective prophylactic treatment of neuraxial opioid-induced pruritus. It was reported that palonosetron is more effective than ondansetron for prevention of postoperative nausea and vomiting. Therefore, the investigators evaluated the efficacy of prophylactic administration of ondansetron and palonosetron for the prevention of intrathecal morphine-induced pruritus.

详细描述

Intrathecal administration of morphine is often used for relief of postoperative pain. However, pruritus is one of the most common side effects associated with intrathecal morphine. Specific serotonin receptor antagonists such as ondansetron could be an effective prophylactic treatment of neuraxial opioid-induced pruritus. It was reported that palonosetron is more effective than ondansetron for prevention of postoperative nausea and vomiting. Therefore, the investigators evaluated the efficacy of prophylactic administration of ondansetron and palonosetron for the prevention of intrathecal morphine-induced pruritus.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 19-70 years,
  • American Society of Anesthesiology physical status 1 and 2
  • Scheduled for elective urologic surgery under spinal anesthesia.

排除标准

  • Patients with cardiac and psychological problems.
  • Patients who take sedatives or narcotics.
  • Patient who have allergy to study drugs.

研究组 & 干预措施

ondansetron

Active Comparator

Intravenous administration of ondansetron 4mg 15 minutes before spinal anesthesia

干预措施: Ondansetron (Drug)

palonosetron

Experimental

Intravenous administration of palonosetron 0.075mg 15 minutes before spinal anesthesia

干预措施: Palonosetron (Drug)

结局指标

主要结局

Incidence of pruritus

时间窗: 24 hours after spinal anesthesia

record of the incidence of pruritus after spinal anesthsia

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Younghoon Jeon

Associate professor

Kyungpook National University Hospital

研究点 (1)

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