Effects of S-medtomidine infusion on pro- and anti-inflammatory cytokines in pediatric open heart surgery

Phase 2

Conditions: Q20-Q28
Condition 1: congenital heart diseases. Condition 2: Congenital malformations of cardiac septa. Condition 3: Congenital malformations of pulmonary and tricuspid valves. Condition 4: Congenital malformations of aortic and mitral valves.
Congenital malformations of the circulatory system
Congenital malformations of cardiac septa
Congenital malformations of pulmonary and tricuspid valves
Congenital malformations of aortic and mitral valves

Registration Number: IRCT2016061927617N2

Lead Sponsor: Vice chancellor for research, Iran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 40

Inclusion Criteria

informed consent of guardians, age below 6, candidate for elective cardiopulmonary bypass surgery, Pump time between 1 to 3 hours; operation time between 4 and 6 hours
Exclusion criteria: infection, coexisting complications, recurrent surgery, deep hypothermia, ejection fraction (EF) below 30%, patients’ death; active infection; operation time more than 5 hours and pump time more than 3 hours, S-medtomidine allergy, administration of S-medtomidine one week before operation

Exclusion Criteria

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IL-6. Timepoint: Before surgery, after declamp and 24 hours post ICU entrance. Method of measurement: ELISA method on plasma.;IL-8. Timepoint: Before surgery, after declamp and 24 hours post ICU entrance. Method of measurement: ELISA method on plasma.;IL-10. Timepoint: Before surgery, after declamp and 24 hours post ICU entrance. Method of measurement: ELISA method on plasma.;TNFa. Timepoint: Before surgery, after declamp and 24 hours post ICU entrance. Method of measurement: ELISA method on plasma.;Heart rate. Timepoint: every 3 hours from operation start until 24 hours post-operation. Method of measurement: Vital sign monitoring system.;Blood pressure. Timepoint: every 3 hours from operation start until 24 hours post-operation. Method of measurement: Vital sign monitoring system.;Respiratory rate. Timepoint: every 3 hours from operation start until 24 hours post-operation. Method of measurement: Vital sign monitoring system.

Secondary Outcome Measures