Effect of Ketamine, at the Induction and Its Maintenance to Prevent the Post-operative Pain: Clinical Trial in Cancerology
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Morphine Consumption (First 48 Post-operative Hours)
研究概览
简要总结
The surgery of breast cancer is responsible for post-operative pain, needing in about 30% some morphine consumption; like that, the association of ketamine with general anaesthesia may decrease morphine's use and so its adverse effects. The purpose is to evaluate the analgesic effect of a receptor NMDA's antagonist ( ketamine)
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ketamine Arm
Anesthetic induction: Ketamine at 0.15 mg/kg is added to the "Reference protocol".
Anesthetic maintenance: Ketamine at 2 mg/kg/min is added to the "Reference protocol".
干预措施: Ketamine (Drug)
Reference Arm
Induction and anesthetic maintenance without ketamine (reference arm / saline solution)
干预措施: Saline solution (Drug)
结局指标
主要结局
Morphine Consumption (First 48 Post-operative Hours)
时间窗: within 48 hours following surgery
Number of participants with at least one consumption of morphine within 48 hours following surgery.
次要结局
- Post-operative Pain(48 hours after surgery)