Levosimendan Versus Combination With Magnesium Sulphate on Spine Protection by NIRS in Infants Undergoing Coarctectomy

Dalia Saad Abd-El Kader

Status and phase: Completed; Phase 4

Conditions: Aortic Coarctation

Treatments: Drug: Levosimendan; Drug: Saline Solution; Drug: Magnesium Sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT04330755

MD-223-2019

Details and patient eligibility

About

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 .

Full 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 .

Enrollment: 40 patients

Sex: All

Ages: 1 day to 12 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

Age group ranging from 0 to 12 months of both sexes. Aortic coarcatation eligible for correction

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 3 patient groups, including a placebo group

Group C

Placebo Comparator group

Description:

Control group will received saline

Treatment:

Drug: Saline Solution

Group L

Active Comparator group

Description:

Levosimendan group will received levosimendan infusion

Treatment:

Drug: Levosimendan

Group M

Active Comparator group

Description:

Levosimendan and Magnesium sulphate group will received both drugs

Treatment:

Drug: Magnesium Sulfate

Drug: Levosimendan