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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016061927617N2

Enrollment

Registered

2016-06-22

Start date

2016-07-15

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

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

Interventions

Intervention 1: Treatment group receives routine anesthesia plus s-medetomidine (0.5 ug/kg/hr). Intervention 2: Control group receives routine anesthesia plus normal saline.

Treatment - Drugs

Placebo

Treatment group receives routine anesthesia plus s-medetomidine (0.5 ug/kg/hr)

Control group receives routine anesthesia plus normal saline

Eligibility

Sex/Gender

All

Age

6 Months to 6 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFazel Gorjipour

Iran University of Medical Sciences

fgorjipour@gmail.com+98 21 8862 2709

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026