Dexmedetomidine and the Inflammatory Response in Pediatric Cardiac Surgery

Phase 2

• Conditions: Cardiac Surgical Procedures
• Interventions: Drug: Dexmedetomidine; Drug: Normal saline

• Registration Number: NCT03163238
• Lead Sponsor: Assiut University

Brief 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

Detailed Description

Dexmedetomidine will be used during Cardiopulmonary bypass-assisted surgery for pediatric cardiac surgery

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-05-19
• Study First Submitted QC: 2017-05-19
• Study First Posted: 2017-05-23
• Study Start: 2017-05-30
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-06
• Last Update Posted: 2018-07-09
• Primary Completion: 2018-10
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group D	Dexmedetomidine	One syringe contain 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.
Group S	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

Primary Outcome Measures

Name	Time	Method
Infilamatory response	Within the first 24 hours	Interleukin 6 and 10

Secondary Outcome Measures

Name	Time	Method
Length of ICU stay	Within 7 days	Length of ICU stay In days
Sedation score	Within the first 24 hours	Special scale
Length of mechanical ventilaton	Within 7 days	Length of mechanical ventilaton In days
Length of hospital stay.	Within 7 days	Length of hospital stay days

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Assiut, Egypt