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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03163238
Other study ID # IRB000087632
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 30, 2017
Est. completion date December 2018

Study information

Verified date July 2018
Source Assiut University
Contact Sayed K Abd-Elshafy, MD
Phone 0882293592
Email sayed_k_72@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

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


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 2018
Est. primary completion date October 2018
Accepts healthy volunteers No
Gender All
Age group 1 Year to 12 Years
Eligibility Inclusion Elective repair of congenital heart disease with cardiopulmonary bypass Exclusion Reintervention surgery requirement for blood products from the start of CPB, preoperative intake of corticosteroids, deep hypothermia, those with preoperative low cardiac output, those with non-palpable peripheral pulses before surgery (e.g., accompanying coarctation of the aorta) or ischemic time during cardiopulmonary bypass more than 90 minutes

Study Design


Related Conditions & MeSH terms


Intervention

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.
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

Locations

Country Name City State
Egypt Faculty of Medicine Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Infilamatory response Interleukin 6 and 10 Within the first 24 hours
Secondary Sedation score Special scale Within the first 24 hours
Secondary Length of mechanical ventilaton Length of mechanical ventilaton In days Within 7 days
Secondary Length of ICU stay Length of ICU stay In days Within 7 days
Secondary Length of hospital stay. Length of hospital stay days Within 7 days
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