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临床试验/NCT02243254
NCT02243254已完成不适用

Prevention of Remifentanil-induced Postoperative Hyperalgesia With Intravenous Ibuprofen

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年7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
120
试验地点
1
主要终点
cumulative morphine consumption

研究概览

简要总结

Postoperative hyperalgesia has been reported after intraoperative administration of small or high-dose remifentanil. Cyclooxygenase inhibitor exhibit preventive effects on the development of opioid-induced hyperalgesia. The aim of this study is to evaluate the preventive effect of intravenous ibuprofen (Caldolor®) on remifentanil-induced hyperalgesia

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • Adult patients scheduled for elective pancreaticoduodenectomy

排除标准

  • Patients with chronic pain
  • Patients with psychiatric disease
  • Patients with nonsteroidal antiinflammatory drugs allergy
  • Patients with renail dysfunction
  • History of drug addiction
  • Pregnant patient
  • Inability to use a PCA device

研究组 & 干预措施

high dose remifentanil without ibuprofen

Placebo Comparator

remifentanil target-controlled infusion effect-site concentration 4 ng/ml normal saline before surgical incision

干预措施: high dose remifentanil (Drug)

low dose remifentanil without ibuprofen

Placebo Comparator

remifentanil target-controlled infusion effect-site concentration 1 ng/ml normal saline before surgical incision

干预措施: low dose remifentanil (Drug)

high dose remifentanil with ibuprofen

Active Comparator

remifentanil target-controlled infusion effect-site concentration 4 ng/ml Intravenous ibuprofen 800 mg before surgical incision

干预措施: high dose remifentanil (Drug)

high dose remifentanil with ibuprofen

Active Comparator

remifentanil target-controlled infusion effect-site concentration 4 ng/ml Intravenous ibuprofen 800 mg before surgical incision

干预措施: Ibuprofen (Drug)

low dose remifentanil with ibuprofen

Active Comparator

remifentanil target-controlled infusion effect-site concentration 1 ng/ml Intravenous ibuprofen 800 mg before surgical incision

干预措施: Ibuprofen (Drug)

low dose remifentanil with ibuprofen

Active Comparator

remifentanil target-controlled infusion effect-site concentration 1 ng/ml Intravenous ibuprofen 800 mg before surgical incision

干预措施: low dose remifentanil (Drug)

结局指标

主要结局

cumulative morphine consumption

时间窗: postoperative 48 hours

cumulative patient-controlled analgesia (PCA) morphine consumption

次要结局

  • Pain score(postoperative 1, 3, 6,12, 24, 48 hours Pain score)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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