NCT01022840已完成3 期
The Opioid Sparing Effect of Minimal Dose S-Ketamine Applied as a Coanalgesic During the Perioperative Period - An Active Placebo-Controlled, Double Blinded, Randomized Clinical Trial (МiniKet)
Medical University of Graz2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- postoperative opioid consumption
研究概览
简要总结
The primary hypothesis is improved postoperative analgetic quality using S-Ketamine, particularly in patients suffering from chronic pain.
详细描述
The investigators are dealing mainly with the finding of the right dosage for the optimal safety and efficacy of S-Ketamine, but also discovering new possible areas of investigation (e.g. anti-depressive effect, anti-neuropathic effect).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for major abdominal surgery
- •Suitable for PCA
- •Cardio-vascular stable
- •Between 50-120kg BW
- •Good Compliance for pain monitoring
排除标准
- •Allergy to S-Ketamine
- •Severe liver or kidney dysfunction
- •Severe coronary disease
- •Pregnancy
- •Present or past psychotic disorders
- •Addiction to alcohol or opioids
- •Poor compliance
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo as saline solution
干预措施: Placebo Comparison (Other)
Low dose
Experimental
S-Ketamine
干预措施: S-Ketamine (Drug)
High dose
Active Comparator
干预措施: S-Ketamine (Drug)
结局指标
主要结局
postoperative opioid consumption
时间窗: 1 year
次要结局
未报告次要终点
研究者
Andreas Sandner-Kiesling , MD
Univ. Prof. Dr.
Medical University of Graz
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Ketamine in Post-operative Dental Pain and RecoveryPost-operative PainNCT02021240The University of Hong Kong150
已完成
2 期
A Comparison of Ketamine Infusion Versus Placebo in Opioid Tolerant and Opioid Naive Patients After Spinal FusionSpinal FusionNCT03274453NYU Langone Health129
已完成
4 期
Efficacy of Ketamine for Improvement in Postoperative Pain Control After Spinal Fusion for Idiopathic ScoliosisIdiopathic ScoliosisPost-operative PainNCT02651324Albany Medical College50
已完成
4 期
Low Doses of Ketamine and Postoperative Quality of RecoveryPostoperative PainPostoperative Nausea and VomitingNCT02571153Pontificia Universidade Catolica de Sao Paulo135
尚未招募
不适用
Reduction in total requirement of opioid by using intravenous Ketamine infusion in very low doses for pain control after free flap reconstruction for oral defects.CTRI/2020/09/028057TMC trust