EUCTR2020-002143-27-NL进行中（未招募）1 期
Spinal morphine in patients with hip fractures to reduce delirium - SALMON-mind
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 364
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Scheduled for surgical treatment of a proximal femur fracture
- •Planned spinal anesthesia.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 214
排除标准
- •Contraindications for spinal anesthesia:
- •- Coagulation disorders (clopidogrel, INR>1.8, anticoagulation with nadroparine (>100 aXa-IE/kg) or heparine (APTT> 30 sec)
- •- Aortic Valve Stenosis of AVA < 1.0 cm2
- •- Lumbar malformations (local inflammation, lumbar osteosynthesis material, meningocele, tethered cord)
- •- Inability to retrieve cerebrospinal fluid by lumbar puncture.
- •Contra-indications for intrathecal morphine:
- •- Chronic opioid or benzodiazepine use (>1 month daily use).
- •- Allergies to amide-type local anesthetics
- •- Patients’ refusal
研究者
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