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

Dalia Saad Abd-El Kader40 enrolled

Overview

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 .

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 .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Aortic Coarctation

Interventions

Saline SolutionDRUG

Placebo

LevosimendanDRUG

Levosimendan

Magnesium SulfateDRUG

Magnesium Sulfate

Eligibility

Sex: ALLMin age: 1 DayMax age: 12 Months

Medical Language ↔ Plain English

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

Locations (1)

Sara ABD El-Salam

Cairo, Egypt

Outcomes

Primary Outcomes

Near Infrared Spectroscopy value

After aortic cross clamping to compare the spinal cord protective effect of levosimendan versus its combination with magnesium sulphate.

Time frame: Perioperative(immediately before cross clamp,10&20 min after cross clamping Aorta)

Data from ClinicalTrials.gov

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