Heart Defects, Congenital, Myocardial Reperfusion Injury
Conditions
Keywords
Congenital open heart surgery, acyanotic, anesthetic preconditioning, opioid, myocardial protection
Brief summary
This study compared two opioid pain medications - morphine and fentanyl - used during open-heart surgery in young children born with heart defects (congenital heart disease). During open-heart surgery, the heart is temporarily stopped to allow surgeons to repair the defect. This process can cause damage to the heart muscle due to reduced blood flow and its restoration, known as ischemia-reperfusion injury, which is one of the leading causes of complications in children undergoing heart surgery. Morphine is known to activate specific receptors in the heart that may help protect it against this type of injury - a process called pharmacological preconditioning. While fentanyl has largely replaced morphine in pediatric cardiac anesthesia over the years, emerging evidence suggests that morphine may have unique heart-protective properties that fentanyl lacks. The purpose of this study was to investigate whether morphine provides better heart muscle protection than fentanyl in children with non-cyanotic congenital heart disease undergoing elective open-heart surgery. The study also aimed to compare postoperative recovery, need for heart-supporting medications, and other clinical outcomes between the two groups.
Interventions
DRUGFentanyl (IV)
Patients received fentanyl 1.5 µg/kg intravenously at anesthesia induction, followed by 1.5 µg/kg before skin incision, with maintenance via continuous infusion at 1 µg/kg/h throughout surgery.
DRUGmorphine
Patients received morphine 0.15 mg/kg intravenously at anesthesia induction, followed by 0.15 mg/kg before skin incision, with maintenance via continuous infusion at 0.1 mg/kg/h throughout surgery.
Sponsors
Baskent University
Baskent University Ankara Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the differing dosing regimens and administration routes of the two opioids, and the need for precise weight-based dose titration in pediatric patients, blinding of the care provider and investigator was not feasible. However, the paediatric cardiologists performing echocardiographic assessments, the laboratory personnel analysing blood biomarker levels, and the investigators assessing postoperative outcomes were blinded to group allocation.
Eligibility
Sex/Gender
ALL
Age
1 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
* Acyanotic children * aged 1-6 years * scheduled for elective congenital open-heart surgery requiring cardiopulmonary bypass
Exclusion criteria
* reoperative surgery, * preoperative hemodynamic instability or inotropic support * history of myocarditis, renal failure, congestive heart failure, hypertrophic cardiomyopathy, severe pulmonary disease requiring mechanical ventilation, pulmonary embolism, hypothyroidism, familial muscle disease * known allergy to morphine or fentanyl * prior cardioversion or cardiopulmonary resuscitation * cyanotic heart disease * age outside the 1-6 year range.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| comparison of myocardial protection | -Venous blood samples were collected at three time points: before skin incision (malondialdehyde1), at the end of surgery (malondialdehyde2), 6 hour postoperatively (malondialdehyde3) | -plasma malondialdehyde (ng/ml) levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| secondary outcome | perioperatively | -inotrope and vasopressor requirements (mcg/kg/min) |
| Secondary Outcome | periprocedurally | opioid and sedative requirements (mcg, mg) |
Countries
Turkey (Türkiye)
Outcome results
None listed