A Phase 4 interventional study of Fentanyl (IV) and morphine in Heart Defects, Congenital and Myocardial Reperfusion Injury, sponsored by Baskent University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 1 Year to 6 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Baskent University · Phase 4, Interventional, and Supportive care
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Among 32 studies in Heart Defects, Congenital with a site in Turkey — 11 open to participants now, 12 under way, none of them phase 3. Heart Defects, Congenital · Turkey.
Among the 32 studies in Heart Defects, Congenital with a site in Turkey, this one is the 6th largest by enrollment of the 18 interventional ones that give a count, is one of 6 that started in 2022, is the only one in phase 4, and was the 31st registered.
991 studies on the registry are indexed under Heart Defects, Congenital; 251 are open to participants now.
Browse Heart Defects, Congenital studies →11 of the 32 studies in Heart Defects, Congenital with a site in Turkey are open now. Recruiting first, the newest first:
Baskent University · Sites in Turkey
Ages 2 mo–12 mo
Fondation Hôpital Saint-Joseph · Sites in Turkey, Denmark, Egypt and 14 more countries
Ages 1 mo+
Ankara Yildirim Beyazıt University · Sites in Turkey
Ages 16–20
Hacettepe University · Sites in Turkey
Ages 8–55 · Healthy volunteers
Occlutech International AB · Sites in Turkey, Ireland, United Kingdom
Ages 3 mo–80 yrs
A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →
Of the 154 Heart Defects, Congenital studies recruiting now, 67 (44%) set no upper age limit and 79 (51%) stop at 75 or younger; 110 take children under 18; 25 take healthy volunteers.
This study: 1 Year to 6 Years · all sexes · no healthy volunteers.
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32 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 6 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 66 is close to the median of 60 across 507 interventional studies indexed under Heart Defects, Congenital.
Median enrollment 51 across the 18 interventional studies, 71 across the 14 observational. Of the 15 that completed or were terminated, 0 (0%) have results posted.
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1 of 32 have an industry lead sponsor. The 10 most frequent:
Baskent University is the lead sponsor of 209 studies on the registry; 35 are open to participants now.
Baskent University has 3 studies filed under Heart Defects, Congenital — fewer than ten, so there is no comparison to draw.
5 of the studies in Heart Defects, Congenital with a site in Turkey that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05684562Hacettepe UniversityPulmonary Determinants of Cardiorespiratory Fitness in Fontan Patients | 2026-12-25 |
| NCT06823635Fondation Hôpital Saint-JosephAn International Multicenter Study on Transcatheter Device Closure of Perimembranous Ventricular Septal Defects | 2026-12-31 |
| NCT07564882Baskent UniversityThe Effect of Music and Musical Mobile Interventions on Pain and Physiological Parameters | 2027-04-30 |
| NCT07575451Cukurova UniversityEmpowering Families in Pediatric Cardiovascular Surgery: A RAM-Based Approach | 2027-06-15 |
| NCT07319858Istanbul University - CerrahpasaThe Effect of Using Multifunctional Baby Carrier With Heart Surgery | 2027-08 |
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Among the 32 studies in Heart Defects, Congenital with a site in Turkey, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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Exclusion Criteria:
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.
Drug: Fentanyl (IV)
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.
Drug: morphine
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.
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.
comparison of myocardial protection
-plasma malondialdehyde (ng/ml) levels
Time frame: -Venous blood samples were collected at three time points: before skin incision (malondialdehyde1), at the end of surgery (malondialdehyde2), 6 hour postoperatively (malondialdehyde3)
comparison of myocardial protection
plasma glutathione (ng/ml) levels
Time frame: Venous blood samples were collected at three time points: before skin incision (glutathione1), at the end of surgery (glutathione2), and 6 h postoperatively (glutathione3)
comparison of myocardial protection
echocardiographic parameters (left ventricular end-diastolic and end-systolic Z scores and EF (%))
Time frame: Transthoracic echocardiography (TTE) was performed before skin incision and at 6 hours postoperatively
secondary outcome
-inotrope and vasopressor requirements (mcg/kg/min)
Time frame: perioperatively
secondary outcome
mechanical ventilation duration (h)
Time frame: from end of the surgery up to extubation
Secondary Outcome
opioid and sedative requirements (mcg, mg)
Time frame: periprocedurally
Secondary Outcome
need for defibrillation (+/-)
Time frame: perioperatively
Secondary Outcome
protamine-related hypersensitivity reactions (+/-)
Time frame: perioperatively
Secondary Outcome
intensive care unit length of stay (day)
Time frame: periprocedurally
Secondary Outcome
hospital length of stay (day)
Time frame: periprocedurally
Secondary Outcome
30-day mortality rates (+/-)
Time frame: from surgery up to 30 days postoperatively
Plan to share: Undecided
Ran from Sep 2022 to primary completion in Sep 2023, 12 months.
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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Morphine