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

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04330755

Enrollment

Registered

2020-04-01

Start date

2021-02-04

Completion date

2023-04-30

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Coarctation

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 .

Interventions

DRUGSaline Solution

Placebo

DRUGLevosimendan

Levosimendan

DRUGMagnesium Sulfate

Magnesium Sulfate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Days to 12 Months

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026