Levosimendan Versus Combination With Magnesium Sulphate on Spine Protection by NIRS in Infants Undergoing Coarctectomy
- Conditions
- Aortic Coarctation
- Interventions
- Registration Number
- NCT04330755
- Lead Sponsor
- Dalia Saad Abd-El Kader
- Brief Summary
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 .
- Detailed Description
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 .
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Age group ranging from 0 to 12 months of both sexes. Aortic coarcatation eligible for correction
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group M Levosimendan Levosimendan and Magnesium sulphate group will received both drugs Group C Saline Solution Control group will received saline Group M Magnesium Sulfate Levosimendan and Magnesium sulphate group will received both drugs Group L Levosimendan Levosimendan group will received levosimendan infusion
- Primary Outcome Measures
Name Time Method Near Infrared Spectroscopy value 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sara ABD El-Salam
🇪🇬Cairo, Egypt