Complication of Anesthesia Clinical Trial
Official title:
The Protective Effect of the α2-agonist Dexmedetomidine on Mitochondrial Structure and Function for Children With Non-cyanotic Congenital Heart Defects Having Cardiac Surgery: A Randomized Controlled Trial.
The investigators hypothesize that in addition to a known sympatholytic effect, intraoperative dexmedetomidine reduces adverse changes in mitochondrial function and structure attenuating ischaemia-reperfusion and end-organ injury for children with non cyanotic congenital heart defects having corrective heart surgery.
PICO: For children with non cyanotic congenital heart defects having corrective heart surgery
(P) does intraoperative dexmedetomidine (I) reduce real-time changes in mitochondrial
function and content (O) compared with children not receiving dexmedetomidine (C).
The study drug (dexmedetomidine or placebo) will be mixed in a standardized syringe of
4mcg/mL for active syringes or 50mL 0.9% sodium chloride for placebo. Blinded syringes will
be prepared by the Research Support Pharmacy.
Administration is via the existing central venous line. A bolus dose of 0.125mL/kg (0.5
mcg/kg dexmedetomidine) infused over 10 minutes will be administered, followed by a
continuous infusion for the duration of the surgery. The dexmedetomidine/placebo continuous
infusion (CI) dose will run at 0.15mL/kg/hr (0.6 mcg/kg/hr dexmedetomidine).
Blood samples will be obtained from each child at three points in the operating room: 1)
after the induction of anesthesia, 2) at the first separation from CPB (prior to
administration of blood products), and 3) at the end of the surgery.
Samples obtained will be analyzed for mitochondrial function and morphology, total cellular
mitochondrial biomass, and mitochondrial deoxyribonucleic acid (mtDNA) damage:
1. After isolating lymphocytes, we will use high content imaging (HCI) to assess
mitochondrial function and morphology. The lymphocytes will be stained with
tetramethylrhodamine methyl ester (TMRM), which stains mitochondria in proportion to
mitochondrial membrane potential, giving a metric for mitochondrial function. In
addition, the cells will be stained with MitoTracker Green®, which can be used to assess
mitochondrial morphology. Mitochondrial morphology will be quantified in a non-biased
fashion using a mathematical image analysis algorithm.
2. After extraction of genomic DNA, total cellular mitochondrial biomass and mitochondrial
DNA damage will be measured using traditional and long-patch quantitative polymerase
chain reaction (PCR).
Myocardial tissue will be also collected prior to closure of the atriotomy. Samples will be
placed into 3% buffered glutaraldehyde at the time of biopsy, and imaging of mitochondrial
structure using electron microscopy will be performed.
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