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NCT04330755 Clinical Trial

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

Aortic Coarctation Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04330755
Other study ID # MD-223-2019
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date February 4, 2021
Est. completion date April 30, 2023

Study information
Verified date April 2021
Source Kasr El Aini Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 .

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 information / eligibility
Status Completed
Enrollment 40
Est. completion date April 30, 2023
Est. primary completion date March 30, 2023
Accepts healthy volunteers No
Gender All
Age group 1 Day to 12 Months
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Saline Solution
Placebo
• Levosimendan
Levosimendan
• Magnesium Sulfate
Magnesium Sulfate

Locations
Country Name City State
Egypt Sara ABD El-Salam Cairo

Sponsors (2)
Lead Sponsor Collaborator
Dalia Saad Abd-El Kader Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Near Infrared Spectroscopy value After aortic cross clamping to compare the spinal cord protective effect of levosimendan versus its combination with magnesium sulphate. Perioperative(immediately before cross clamp,10&20 min after cross clamping Aorta)
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