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The effect of dexmedetomidine on neuroprotection in pediatric cardiac surgery patients: study protocol for a
Sang-Hwan Ji1, Pyoyoon Kang1, In-Sun Song1
1Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Korea.
Insights
Dexmedetomidine may protect infants from neurodevelopmental delays after heart surgery. This study investigates its neuroprotective effects and impact on other organs in infants undergoing cardiopulmonary bypass.
Area of Science:
- Pediatric Cardiac Surgery
- Neuroprotection
- Pharmacology
Background:
- Infants undergoing cardiopulmonary bypass for cardiac surgery face risks of neurodevelopmental delays.
- Dexmedetomidine demonstrates potential organ-protective effects in preclinical and adult studies.
- This research explores dexmedetomidine's neuroprotective capacity in infants during cardiac surgery.
Purpose of the Study:
- To evaluate the neuroprotective effect of dexmedetomidine in infants undergoing cardiac surgery with cardiopulmonary bypass.
- To assess the impact of dexmedetomidine on early neurodevelopmental outcomes.
- To examine dexmedetomidine's effects on other organ systems and perioperative adverse events.
Main Methods:
- A prospective, double-blind, randomized controlled trial involving 160 infants.
- Infants received either dexmedetomidine infusion or a placebo (normal saline).
- Primary outcome: neurodevelopmental scores (Bayley Scales of Infant Development-III) at 1 year; secondary outcomes: biomarkers and adverse events.
Main Results:
- The study is designed to determine if dexmedetomidine reduces the incidence of neurodevelopmental delays.
- It will also compare changes in biomarkers like glial fibrillary acidic protein and troponin I.
- Perioperative major adverse events will be analyzed between groups.
Conclusions:
- This trial will ascertain if dexmedetomidine use improves early neurodevelopmental outcomes in infants post-cardiac surgery.
- The study will provide insights into dexmedetomidine's broader organ-protective effects.
- Findings will inform clinical practice regarding perioperative medication in pediatric cardiac surgery.
Background:
Infants undergoing cardiac surgery under cardiopulmonary bypass are vulnerable to postoperative neurodevelopmental delays. Dexmedetomidine has been shown to have protective effects on the heart, kidneys, and brain in animals and adults undergoing cardiac surgery with cardiopulmonary bypass. We hypothesized that dexmedetomidine would have a neuroprotective effect on infants undergoing cardiopulmonary bypass and planned a prospective randomized controlled trial with postoperative neurodevelopment measurements.
Methods:
This is a single-center, prospective, double-blinded, randomized controlled trial with 1:1 allocation. A cohort of 160 infants undergoing cardiac surgery with cardiopulmonary bypass will be enrolled. After induction, dexmedetomidine will be infused with a loading dose of 1 μg/kg and a maintenance dose of 0.5 μg/kg/h or the same amount of normal saline will be administered. Upon initiation of cardiopulmonary bypass, an additional dose of dexmedetomidine (0.01 μg/cardiopulmonary priming volume) will be mixed with the cardiopulmonary bypass circuit. The primary outcome will be the proportion of infants who score lower than 85 in any of the cognitive, language, or motor Bayley scales of infant development-III tests 1 year after the surgery. Other feasible outcome measures will include differences in plasma glial fibrillary acidic protein, troponin I, interleukin-6, urinary neutrophil gelatinase-associated lipocalin, and perioperative major adverse events. The results of the Bayley scales of infant development-III test from the study group and the control group will be compared using a chi-squared test under intention-to-treat analysis. A generalized estimating equation will be used to analyze repeated measurements over time.
Discussion:
This study will enable us to assess whether the use of dexmedetomidine can alter the early neurodevelopmental outcome in infants undergoing cardiac surgery with cardiopulmonary bypass and also estimate effects of dexmedetomidine on other organs.
Trial Registration:
ClinicalTrials.gov NCT04484922. Registered on 24 July 2020.
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