The Central Nervous Penetration of Dexketoprofen and Etoricoxib and Their Effect on Pain and Inflammatory Reaction in Patients Undergoing Hip Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 主要终点
- Cerebrospinal fluid concentration dexketoprofen and etoricoxib
研究概览
简要总结
The main purpose of this study was to determine the plasma and central nervious system pharmacokinetics of dexketoprofen and etoricoxib. The secondary aim was to asses their effect on the concentrations of interleukin 6, prostaglandin E2 and other proinflammatory markers both in plasma and cerebrospinal fluid. Thirdly, the investigators aimed to evaluate their efficacy in postoperative pain treatment.
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
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •agreed to participate the study
- •American Society of Anesthesiologist s physical status classification 1-3
- •elective hip arthroplasty planned
- •no contraindications to the study drugs
- •no contraindication to lumbar puncture
排除标准
- •refused to participate the study
- •age less than 40 or over 75 years
- •Planned anesthesia method other than spinal anesthesia
- •contraindications to the study drugs
- •Contraindications to lumbar puncture
研究组 & 干预措施
Etoricoxib
Etoricoxib 60mg if body weight≤ 60kg, 90mg if body weight 61-90kg and 120mg if body weight> 90kg by mouth
干预措施: Etoricoxib (Drug)
Dexketoprofen
Dexketoprofen 0,5 mg/kg up to 50 mg intravenously
干预措施: Dexketoprofen (Drug)
结局指标
主要结局
Cerebrospinal fluid concentration dexketoprofen and etoricoxib
时间窗: 0-24 hours
Cerebrospinal fluid concentration of dexketoprofen and etoricoxib
Plasma concentration dexketoprofen and etoricoxib
时间窗: 0-24 hours
Plasma concentration dexketoprofen and etoricoxib
次要结局
- Pain(0-24 h)
研究者
Merja Kokki
MD, PhD
Kuopio University Hospital