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临床试验/NCT01169805
NCT01169805已完成不适用

Prophylactic Effects of Ondansetron, Ramosetron, and Palonosetron on Patient-Controlled Analgesia Related Nausea and Vomiting After Urologic Laparoscopic Surgery

Yonsei University1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2010年8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
105
试验地点
1
主要终点
severity of nausea

研究概览

简要总结

The aim of this prospective randomized controlled study was to compare the prophylactic effects of intravenous single dose of ondansetron, ramosetron, and palonosetron on PCA-related nausea and vomiting after urologic laparoscopic surgery.

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 (Care Provider, Investigator)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • ASA I or II
  • Patients aged (20-65 yr) Undergoing Laparoscopic Nephrectomy
  • Patients who want a patient-controlled IV analgesia (IV-PCA)

排除标准

  • History of allergy or hypersensitivity to 5-HT3 antagonist
  • History of severe postoperative nausea/vomiting
  • Prolonged QT interval on preoperative EKG
  • Hypokalemia, Hypomagnesemia
  • Intestinal obstruction
  • Pregnant female or breast feeding mother

研究组 & 干预措施

ONSERAN

Experimental

干预措施: Ondansetron (Drug)

NASEA

Experimental

干预措施: Ramosetron (Drug)

ALOXI

Experimental

干预措施: Palonosetron (Drug)

normal saline

Placebo Comparator

干预措施: Normal saline inj (Drug)

结局指标

主要结局

severity of nausea

时间窗: during 73 hours after surgery

the number of vomiting

时间窗: during 73 hours after surgery

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

Hae Keum Kil

Professor

Yonsei University

研究点 (1)

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