EUCTR2014-000839-16-DK进行中（未招募）不适用
The effect of intraoperative ketamine on opioid consumption and pain after spine surgery in opioid-dependent patients
HovedOrtoCentret, Rigshospitalet0 个研究点目标入组 160 人开始时间: 2014年3月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
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
- •Patients undergoing lumbar spinal fusion surgery i generel anaesthesia.
- •Daily use of opioids for a minimum of 6 weeks preoperatively (morphine, ketobemidon, oxycodon, fentanyl, tramadol and/or buprenorphine).
- •Back pain for a minimum of 3 months preoperatively.
- •Age > 18 years and < 85 years.
- •BMI > 18 and < 40.
- •Fertile women need to have a negative urine HCG pregnancy test.
- •Patients who have given their written informed consent to participate in the study after having fully understood the content and limitations of the study
- •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 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 160
排除标准
- •Participation in another drug trial.
- •Patients who do not understand or speak Danish.
- •Allergy to the drugs used in the trial.
- •Abuse of drugs - assessed by the investigator.
- •Daily methadone use.
- •Increased intraocular pressure - assessed via the patients chart.
- •Uncontrolled hypertension - assessed via the patients chart.
- •Previous and current psychotic episodes - assessed via the patients chart
研究者
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