The Effect of Adding Dexmedetomidine to Modified Del Nido Cardioplegia Solution on Myocardial Protection in Children Undergoing Congenital Heart Defect Surgery - A Prospective, Randomized, Triple-Blind, Controlled Trial.

Q: What are the key findings of this study?

Dexmedetomidine-enriched modified Del Nido cardioplegia lowered postoperative serum troponin I levels at 24 hours compared to standard cardioplegia.

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Congenital heart defects undergoing corrective surgery (n=60). Intervention: Dexmedetomidine-enriched modified Del Nido cardioplegia vs. Standard modified Del Nido cardioplegia with normal saline. Primary outcome: Serum troponin I concentration at 24 hours after ICU admission (p=<0.001).

Q: What does this research mean for the field?

Adding dexmedetomidine to modified Del Nido cardioplegia improves myocardial protection and reduces postoperative troponin I levels, inotropic support requirements, and ICU stay in children undergoing congenital heart defect surgery. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.NEUTRAL.

Farhad Samadieh; Mahmood Hosseinzadeh Maleki; Masoud Razeghian; Tahereh Izanlou; Mohammadreza Naghibi Sistani; Benyamin Fazli; Mohsen Yaghubi

doi:10.21470/1678-9741-2025-0415

July 1, 2026

The Effect of Adding Dexmedetomidine to Modified Del Nido Cardioplegia Solution on Myocardial Protection in Children Undergoing Congenital Heart Defect Surgery - A Prospective, Randomized, Triple-Blind, Controlled Trial.

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Key result

Dexmedetomidine-enriched Del Nido cardioplegia cuts 24-hour postoperative troponin I ~83% vs standard cardioplegia.

P<0.001
n=60

Figures

Why the study?

Effective myocardial protection against ischemia-reperfusion injury remains a dilemma in pediatric congenital heart defect surgery. This study evaluated the effect of adding dexmedetomidine to modified Del Nido cardioplegia on myocardial protection in children undergoing CHD surgery.

Does adding dexmedetomidine to modified Del Nido cardioplegia improve myocardial protection (reduce troponin I, CK-MB, and coronary sinus lactate) in children undergoing corrective congenital heart defect surgery?

Study Design

Type

RCT (n=60)

Blinding

Triple-blind

Randomization

1:1 computer-generated block randomization with sealed opaque envelopes

Multicenter

Yes

Structured PICO

Does adding dexmedetomidine to modified Del Nido cardioplegia improve myocardial protection (reduce troponin I, CK-MB, and coronary sinus lactate) in children undergoing corrective congenital heart defect surgery?

P

Population

60 pediatric patients older than one month (mean age ~36 months, 51.7% female) undergoing elective corrective surgery for RACHS 1 or 2 congenital heart defects at three centers in Iran, followed through ICU stay.

I

Intervention

Dexmedetomidine added to modified Del Nido cardioplegia solution at a final concentration of 0.1 µg/mL (2 mL of 50 µg/mL dexmedetomidine in 500 mL cardioplegia solution), mixed 4:1 with autologous blood and administered antegrade via the aortic root at 20 mL/kg (with repeat half-volume doses after 90 minutes if required).

C

Comparator

Standard modified Del Nido cardioplegia solution with an equivalent volume of normal saline, mixed 4:1 with autologous blood and administered antegrade via the aortic root at 20 mL/kg.

O

Outcome

Serum troponin I levels and creatine kinase-MB (CK-MB) measured at baseline, ICU admission, and 12 and 24 hours post-ICU admission; and coronary sinus lactate concentrations measured intraoperatively immediately after opening the right atrium, just before aortic cross-clamp removal, and 10 minutes after declamping.surrogate

Main Result

Absolute Event Rate: 0.08% vs 0.47%

p-value: p=<0.001

Limitations

Small sample size limits detection of rarer adverse events or nuanced subgroup effects
Conducted in specialized centers, which may limit generalizability to all surgical settings
Lack of longer-term follow-up to evaluate sustained myocardial or renal function or late morbidity
Precise mechanistic pathways by which dexmedetomidine confers myocardial protection when added to cardioplegia were not investigated
Conducted in specialized centers, limiting generalizability to all surgical settings
Precise mechanistic pathways of cardioprotection were not investigated

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Implication

Adding dexmedetomidine directly to modified Del Nido cardioplegia attenuates myocardial injury biomarkers, reduces vasoactive-inotropic requirements, and shortens mechanical ventilation and ICU stay in children undergoing corrective congenital heart defect surgery.

Abstract

INTRODUCTION: The myocardial ischemia-reperfusion injury (IRI) is an indispensable factor in pediatric congenital heart defect (CHD) surgery. Although effective myocardial protection strategies are crucial, the issue remains a dilemma. This study aimed to evaluate the effect of adding dexmedetomidine to modified Del Nido cardioplegia on myocardial protection in children undergoing CHD surgery. METHODS: This was a prospective, randomized, triple-blind, controlled clinical trial. A total of 60 pediatric patients were enrolled and randomized 1:1 into two groups - an intervention group that received dexmedetomidine-enriched modified Del Nido cardioplegia and a control group that received standard modified Del Nido cardioplegia with normal saline. Primary outcomes included serum troponin I and creatine kinase-MB levels, as well as coronary sinus lactate levels. Secondary outcomes were the vasoactive-inotropic score, weaning time from mechanical ventilation, and intensive care unit length of stay. RESULTS: Adding dexmedetomidine to modified Del Nido cardioplegia significantly improved myocardial protection in children undergoing CHD surgery. The intervention group showed significantly lower troponin I levels at all postoperative time points compared to the control group (P < 0.001). Similarly, the dexmedetomidine group had significantly lower vasoactive-inotropic score at all time points (P < 0.001). Patients in the intervention group also experienced a significantly shorter mean ventilator weaning time (P < 0.001) and intensive care unit stay duration (P < 0.001). The overall distribution of postoperative morbidities did not differ significantly between the groups (P = 0.059). CONCLUSION: Adding dexmedetomidine to modified Del Nido cardioplegia significantly improved myocardial protection in children undergoing corrective CHD surgery.

Discussion

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Cite This Study

Samadieh et al. (2026) conducted an RCT in Congenital heart defects undergoing corrective surgery (n=60). Dexmedetomidine-enriched modified Del Nido cardioplegia vs. Standard modified Del Nido cardioplegia with normal saline was evaluated on Serum troponin I concentration at 24 hours after ICU admission (p=<0.001). Dexmedetomidine-enriched modified Del Nido cardioplegia lowered postoperative serum troponin I levels at 24 hours compared to standard cardioplegia.

synapsesocial.com/papers/6af0e999de503f3774140a43 https://doi.org/10.21470/1678-9741-2025-0415

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The Effect of Adding Dexmedetomidine to Modified Del Nido Cardioplegia Solution on Myocardial Protection in Children Undergoing Congenital Heart Defect Surgery - A Prospective, Randomized, Triple-Blind, Controlled Trial.

Figures

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

The Effect of Adding Dexmedetomidine to Modified Del Nido Cardioplegia Solution on Myocardial Protection in Children Undergoing Congenital Heart Defect Surgery - A Prospective, Randomized, Triple-Blind, Controlled Trial.

Figures

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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