The Effect of Levosimendan Versus Its Combination to Magnesium Sulphate on Spinal Cord Protection Guided by NIRS in Infants Undergoing Coarctectomy: A Randomized Controlled Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Near Infrared Spectroscopy value
研究概览
简要总结
In pediatric patients ,undergoing elective surgical correction of aortic coarcatation one of our main concern is spinal cord protection .Our aim to study the protective effect of levosimendan versus its combination with magnesium sulphate .
详细描述
Effect of levosimendan and its combination with magnesium sulphate infusion as spinal cord protection using NIRS values before Aortic cross clamp and 10,20 min after cross clamp till the end of surgery .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age group ranging from 0 to 12 months of both sexes. Aortic coarcatation eligible for correction
排除标准
- •Parents or guardian refusal. Age more than12 months. Significant left ventricular dysfunction Patient with Heart block Patient with pre-existing CNS disorder eg seizure Patient with renal or hepatic dysfunction
研究组 & 干预措施
Group C
Control group will received saline
干预措施: Saline Solution (Drug)
Group L
Levosimendan group will received levosimendan infusion
干预措施: Levosimendan (Drug)
Group M
Levosimendan and Magnesium sulphate group will received both drugs
干预措施: Levosimendan (Drug)
Group M
Levosimendan and Magnesium sulphate group will received both drugs
干预措施: Magnesium Sulfate (Drug)
结局指标
主要结局
Near Infrared Spectroscopy value
时间窗: Perioperative(immediately before cross clamp,10&20 min after cross clamping Aorta)
After aortic cross clamping to compare the spinal cord protective effect of levosimendan versus its combination with magnesium sulphate.
次要结局
未报告次要终点
研究者
Dalia Saad Abd-El Kader
Principle investigator
Kasr El Aini Hospital