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临床试验/NCT01863355
NCT01863355Unknown不适用

Comparison of Analgesic Efficacy and Occurrence of Emesis Among Different Background Infusion and Bolus Administration Regimens of Fentanyl Based Intravenous Patient-controlled Analgesia in Patients After Laparoscopic Assisted Gastrectomy - a Randomized Blind Study -

Yonsei University2 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2013年5月最近更新:
适应症
相关药物

试验速览

阶段
不适用
入组人数
225
试验地点
2
主要终点
Pain score(VAS) within 48hrs after surgery

研究概览

简要总结

Fentanyl based intravenous patient controlled analgesia(PCA)is popular method for postoperative pain control, but information regarding optimal dose of fentanyl in IV PCA is currently lacking. We thus determine appropriate dose of fentanyl (bolus dose and background infusion rate) for effective pain control with minimal side effects such as nausea and vomiting

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Age between 20 and 70
  • ASA class I and II
  • Gastric cancer patients who are scheduled to receive laparoscopic gastrectomy

排除标准

  • Cardiovascular disease(uncontrolled hypertension, unstable angina, congestive heart failure, etc.)
  • Renal failure
  • Liver failure
  • Chronic drug or alcohol abuser
  • Anti-cancer chemotherapy
  • Chronic opioid use
  • Use of antiemetics within 24hrs for nausea and vomiting

结局指标

主要结局

Pain score(VAS) within 48hrs after surgery

时间窗: Pain socre after surgery 1) within 30min-6hrs, 2) within 6-24hrs, 3) within 24hrs-48hrs

Pain score after surgery within 48hrs after laparoscopic gastrectomy

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 (2)

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