NCT02994173已完成4 期
Dose Response Study of Patient Controlled Analgesia (PCA) of S-ketamine in Orthopaedic Spine Surgery Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in opioid consumption (mg) postoperatively
研究概览
简要总结
To study the multimodal protocol combining adjunct ketamine with oxycodone in intravenous patient-controlled analgesia bolus dosing and effects in patients scheduled for posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 - 75 years of age
- •Scheduled for elective posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation under general anaesthesia.
- •Written informed consent from the participating patient
排除标准
- •A previous history of intolerance to the study drug or related compounds and additives
- •Concomitant drug therapy with opioids or strong CYP3A4 or CYP2B6 inductor(s) or inhibitor(s) 2 weeks prior to study.
- •Patients younger than 20 years and older than 75 years.
- •BMI > 35, sleep apnoea, any other sleep disorder or condition that requires treatment with continuous positive airway pressure or automatic positive airway pressure device.
- •Existing significant liver or kidney disease
- •History of ischemic heart disease or conduction disturbance
- •History of alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent
- •Donation of blood for 4 weeks prior and during the study.
研究组 & 干预措施
Placebo
Active Comparator
Oxycodone 1 mg / ml alone
干预措施: Oxycodone (Drug)
Ketamine 0.25
Active Comparator
Oxycodone 1 mg / ml + S-ketamine 0.25 mg / ml (ratio 1:0.25)
干预措施: S-Ketamine 0.25 (Drug)
Ketamine 0.5
Active Comparator
Oxycodone 1 mg / ml + S-ketamine 0.5 mg / ml (ratio 1:0.5)
干预措施: S-Ketamine 0.5 (Drug)
Ketamine 0.75
Active Comparator
Oxycodone 1 mg / ml + S-ketamine 0.75 mg / ml (ratio 1:0.75)
干预措施: S-Ketamine 0.75 (Drug)
结局指标
主要结局
Change in opioid consumption (mg) postoperatively
时间窗: 24 and 72 hours
Change from baseline opioid consumption (mg) postoperatively at 24 and 72 hours
次要结局
- Change in numerical rating scale (NRS 0-10)(24 and 72 hours)
研究者
研究点 (1)
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