跳至主要内容
临床试验/NCT03409835
NCT03409835Unknown不适用

Effect of Ramosetron on Post-discharge Nausea and Vomiting in Patients Undergoing Gynecologic Surgery Through a Day-surgery Center

Seoul National University Bundang Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
The change in the occurrence of postoperative vomiting

研究概览

简要总结

Nausea and vomiting after general anesthesia is one of the common anesthetic complications. If the patient is discharged from the hospital after surgery, proper treatment may be delayed or impossible if nausea or vomiting occurs. Thus, It is necessary to prevent these symptoms beforehand. Patients who underwent gynecologic surgery will be treated with prophylactic ramosetron to determine whether the frequency of nausea and vomiting is decreased when the patient returned home after discharge.

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
20 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients who undergo hysteroscopic surgery and are discharged on the day of surgery.

排除标准

  • American Society of Anesthesiologists physical statue 3 or more
  • Planned admission after surgery
  • Intravenous anesthesia
  • During chemotherapy
  • Pregnancy or breastfeeding
  • Abnormal liver or kidney function

研究组 & 干预措施

Ramosetron

Experimental

干预措施: Ramosetron (Drug)

Control

Placebo Comparator

干预措施: Normal saline (Drug)

结局指标

主要结局

The change in the occurrence of postoperative vomiting

时间窗: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour

The change in the occurrence of postoperative nausea

时间窗: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour

次要结局

  • The change in the number of postoperative administration of rescue antiemetic drug(Postoperative 30 minute and 3 hour)
  • The change of patient's satisfaction score(Postoperative 30 minute, 3 hour, 24 hour, and 48 hour)
  • The change of postoperative pain score(Postoperative 30 minute, 3 hour, 24 hour, and 48 hour)
  • The change in the number of postoperative administration of rescue analgesic drug(Postoperative 30 minute and 3 hour)

研究者

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

Hyo-Seok Na

Principle investigator

Seoul National University Bundang Hospital

研究点 (1)

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