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临床试验/NCT02325882
NCT02325882已完成不适用

The Postoperative Analgesic Effect of Combination With Dexmedetomidine in Fentanyl-based Intravenous Patient Controlled Analgesia Compared With Conventional Thoracic Epidural and Intravenous Patient Controlled Analgesia After Radical Open Gastrectomy

Yonsei University1 个研究点 分布在 1 个国家目标入组 171 人开始时间: 2015年3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
171
试验地点
1
主要终点
Postoperative pain

研究概览

简要总结

The aim of this study to test hypothesis that addition of dexmedetomidine to fentanyl based intravenous patient controlled analgesia (PCA) improves postoperative pain compared with conventional thoracic epidural and intravenous patient controlled analgesia after radical open gastrectomy.

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
None

入排标准

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

入选标准

  • ASA class I-II
  • obtaining written informed consent from the parents
  • aged 20-65 years who were undergoing radical open gastrectomy

排除标准

  • abdominal surgery previously
  • patient who refuse the patient controlled analgesia
  • unstable angina or congestive heart failure
  • uncontrolled hypertension (diastolic bp>110mmHg)
  • coagulopathy
  • hepatic failure
  • renal failure
  • bradycardia on EKG (under 50 bpm)
  • Ventricular conduction abnormality
  • drug hyperactivity
  • neurological or psychiatric illnesses
  • mental retardation
  • patients who can't read the consent form due to illiterate or foreigner 14.infection
  • obesity (BMI > 30kg/m2)

研究组 & 干预措施

Conventional fentanyl-based intravenous PCA

Active Comparator

干预措施: Fentanyl 2 (Drug)

Conventional fentanyl-based epidural PCA

Active Comparator

干预措施: Fentanyl 1 (Drug)

dexmedetomidine to fentanyl-based intravenous PCA

Experimental

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

Postoperative pain

时间窗: 48 hours after operation

Postoperative pain measure using verbal numerical rating scales (VNRS) for 48 hrs

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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