Here is the design of a clinical trial:

Official Title: The Effect of Dexmedetomidine on Neuroprotection in Pediatric Cardiac Surgery Patients: a Randomized Controlled Trial

Included conditions:
- Congenital Heart Disease

Study Armgroups:
- {'label': 'Dexmedetomidine', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Dexmedetomidine']}
- {'label': 'Control', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Drug: Normal saline']}

Interventions:
- {'type': 'DRUG', 'name': 'Dexmedetomidine', 'description': 'continuous infusion of dexmedetomidine during the surgery', 'armGroupLabels': ['Dexmedetomidine']}
- {'type': 'DRUG', 'name': 'Normal saline', 'description': 'continuous infusion of normal saline during the surgery', 'armGroupLabels': ['Control']}

Primary Outcomes:
- {'measure': 'Bayley scales of Infant development', 'description': 'Developmental outcomes at each assessment and within each domain (cognitive, language, and motor) were classified as "average" if they were within 1 SD of the mean or higher (scores .85), "at risk" if they were 1 to 2 SD below the mean (scores 70-84), and "delayed" if they were .2SD below the mean (,70). The trajectory of development over time in each domain (cognitive, language, and motor)', 'timeFrame': '1 year after the surgery'}

Please estimate the sample size based on the assumption: 
Alpha error of 5%, power of 80%, and a dropout ratio of 20%.
Sample size {14}
        In a previous study, 75% of patients who underwent surgery with cardiopulmonary bypass during infancy or cardiac surgery during the neonatal period were marked below 85 at BSID within 3âyears [42]. We assumed that dexmedetomidine infusion could reduce the proportion of patients with low BSID from 75 to 50%. With an alpha error of 5% and power of 80%, 132 patients with a 1:1 allocation to the study group and the control group will be required. Considering the relatively long time span between enrollment and follow-up, we set the dropout ratio to be close to 20%. Finally, we plan to enroll 160 patients with a 1:1 allocation ratio to each group.