Dose Response Study of Patient Controlled Analgesia (PCA) of Dexmedetomidine in Orthopaedic Spine Surgery Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 107
- 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 dexmedetomidine 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
- Triple (Participant, Care Provider, Investigator)
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
- •Scheduled for elective posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation under general anaesthesia.
- •Written informed consent from the participating subject
排除标准
- •A previous history of intolerance to the study drug or related compounds and additives
- •Concomitant drug therapy with oxycodone or buprenorphine.
- •History of ischemic heart disease or conduction disturbance
- •BMI > 35
- •Existing significant haematological, endocrine, metabolic or gastrointestinal disease
- •History of alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent
- •Allergy to dexmedetomidine or oxycodone
- •Blood loss exceeding 1500 ml during operation
研究组 & 干预措施
Placebo
Oxycodone 1 mg / ml alone
干预措施: Oxycodone (Drug)
Dexmedetomidine 2.5
Oxycodone 1 mg / mL + Dexmedetomidine 2,5 μg / mL
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine 2.5
Oxycodone 1 mg / mL + Dexmedetomidine 2,5 μg / mL
干预措施: Oxycodone (Drug)
Dexmedetomidine 5
Oxycodone 1 mg / mL + Dexmedetomidine 5 μg / mL
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine 5
Oxycodone 1 mg / mL + Dexmedetomidine 5 μg / mL
干预措施: Oxycodone (Drug)
Dexmedetomidine 10
Oxycodone 1 mg / mL + Dexmedetomidine 10 μg / mL
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine 10
Oxycodone 1 mg / mL + Dexmedetomidine 10 μg / mL
干预措施: Oxycodone (Drug)
结局指标
主要结局
Change in opioid consumption (mg) postoperatively
时间窗: 24 hours
Change from baseline opioid consumption (mg) postoperatively at 24 hours
次要结局
- Change in numerical rating scale (NRS 0-10)(72 hours)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(72 hours)