ISRCTN37500282已完成4 期
The cerebrospinal fluid (CSF) pharmacokinetics of a single pre-operative intravenous bolus dose of diclofenac (Dyloject®) in comparison to diclofenac infusion (Voltarol®): a prospective open-label randomised single-centre phase IV study
Barts and The London NHS Trust (UK)0 个研究点目标入组 20 人开始时间: 2009年2月12日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
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
排除标准
- •1. History of bleeding diathesis or use of anticoagulant or antiplatelet agent
- •2. History of spinal or neurological disease (including raised intracranial pressure), or surgery contraindicating spinal anaesthesia
- •3. Use of aspirin within 72 hours prior to surgery
- •4. Use of other non-steroidal anti-inflammatory drugs (NSAIDs), paracetamol or steroids within 12 hours before surgery
- •5. Hypersensitivity to diclofenac or local anaesthetics
- •6. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) or blood urea nitrogen (BUN) greater than 1.5 x 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 unwilling to undertake a pregnancy test (urinary beta-human chorionic gonadotropin [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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