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Dexmedetomidine and the Inflammatory Response in Pediatric Cardiac Surgery

NCT03163238 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-07-09

No results posted yet for this study

Summary

Cardiopulmonary bypass-assisted surgery initiates a systemic inflammatory response induced by extrinsic (e.g. anesthesia, contact activation within the extracorporeal circuit, endotoxemia) and intrinsic (e.g. tissue damage, endothelial cell activation, ischemia-reperfusion injury of myocardium) factors. This may either be mild or lead to a more severe clinical condition. Inflammation after pediatric open heart surgery is a parameter affecting also duration of mechanical ventilatory support. Dexmedetomidine use was associated with a reduced increase in plasma IL-1, IL-6, TNF-a, and INF-g levels

Conditions

  • Cardiac Surgical Procedures

Interventions

DRUG

Dexmedetomidine

Dexmedetomidine 0.5 mcg/kg diluted with normal saline in Dexmedetomidine group. Second syringe (50 ml) will contain normal saline (0.9%) in addition to Dexmedetomidine in addition to normal saline in Dexmedetomidine group. Concentration of Dexmedetomidine will be diluted according to the body weight so that we will fix the rate of infusion (1 ml/kg) to achieve a concentration of 0.5 mcg/kg/h in Dexmedetomidine group.

DRUG

Normal saline

One syringe contain normal saline in 5 ml in Saline group. Second syringe (50 ml) will contain normal saline (0.9%) alone in rate of infusion (1 ml/kg) in Saline group

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Sayed K Abd-Elshafy, MD · Associate profossor of anesthesiology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-30
Primary Completion
2018-10-31
Completion
2018-12-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03163238 on ClinicalTrials.gov