EUCTR2008-007309-35-GB进行中（未招募）1 期
The Cerebrospinal Fluid (CSF) pharmacokinetics of a single pre-operative intravenous bolus dose of diclofenac (Dyloject) in comparison of diclofenac infusion (Voltarol) - Dyloject CSF Pharmacokinetics
Barts and The London NHS Trust0 个研究点目标入组 0 人开始时间: 2009年1月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
入选标准
- •1.Male or female patients aged at least 18 years.
- •2.Scheduled to undergo surgery performed under spinal anaesthesia
- •3.Patients must be inpatients
- •4.Patient has given written informed consent
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.History of bleeding diathesis or use of anticoagulant or antiplatelet agent.
- •2.History of spinal or neurological disease (incl. raised intracranial pressure), or surgery contraindicating spinal anaesthesia.
- •3.Use of aspirin within 72 hours prior to surgery.
- •4.Use of other NSAID’s, paracetamol or steroids within 12 hours before surgery.
- •5.Hypersensitivity to diclofenac or local anaesthetics.
- •6.AST, ALT or BUN >1.5x the upper limit of the reference range, or creatinine greater than the upper limit of the reference range.
- •7.Any other abnormal laboratory results considered clinically significant in relation to this study by the investigator
- •8.Presence of oliguria, anaemia, hypotension or hypovolaemia
- •9.Contraindications to NSAID / diclofenac
- •10.Patients who are unwilling or unable to conform to the protocol
- •11.Patients who have received an unlicensed drug less than 30 days prior to the study
- •12.Patients who have been previously admitted to the study.
- •13.Pregnant or lactating females or females of child-bearing potential who are unwillingto undertake a pregnancy test (urinary B-HCG).
- •14.A bloody tap (visible blood in CSF)
- •15.Patients with a hypersensitivity to the excipients Hydroxypropylbetadex (HPßCD) or monothioglycerol.
- •16.Operations with high risk of haemorrhage.
- •17.Patients who are considered unsuitable by the responsible anaesthetist - for whom spinal anaesthesia is deemed to constitute an unacceptable, increased risk
- •18.Patients who are involved in existing research.
研究者
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