Dexmedetomidine Neuroprotection in Pediatric Cardiac Surgery

Not Applicable

• Conditions: Congenital Heart Disease
• Interventions: Drug: Normal saline; Drug: Dexmedetomidine

• Registration Number: NCT04484922
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Neurodevelopmental disability is the most significant complication for survivors of infant surgery for congenital heart disease. In this study we sought to determine if intraoperative continuous infusion of dexmedetomidine are associated with neurodevelopmental outcomes at 12 months.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-21
• Study First Submitted QC: 2020-07-23
• Study First Posted: 2020-07-24
• Study Start: 2020-08-25
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-01
• Last Update Posted: 2022-02-02
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Neonates undergoing cardiac surgery
• Infants undergoing cardiac surgery with cardiopulmonary bypass (atrial septal defect repair, ventricular septal defect repair, or tetralogy of fallot repair)

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Exclusion Criteria

• History of hypersensitivity of any drug
• Presence of hypotension or bradycardia considering age Bradycardia (heart rate < 80 beats/min) or hypotension (systolic blood pressure < 70mmHg for infants, < 60mmHg for neonates)
• Elevated liver enzyme levels (aspartate transaminase >100unit/L, alanine aminostrasferase > 50 unit/L)
• surgery with deep hypothermic circulatory arrest
• Presence of complex cardiac defect
• single ventricular physiology
• plan of additional operation within a year
• preoperative use of beta-agonists
• presence of history of any neurological disorder

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Normal saline	-
Dexmedetomidine	Dexmedetomidine	-

Primary Outcome Measures

Name	Time	Method
Bayley scales of Infant development	1 year after the surgery	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)

Secondary Outcome Measures

Name	Time	Method
neurodevelopment biomarker	intraoperative (before skin incision, end of hypothermia, end of cardiopulmonary bypass), 4 hours after end of surgery	plasma glial fibrillary acidic protein concentration
inflammation	4 hours after end of surgery	level of IL-6
acute kidney injury	2 hours after end of cardiopulmonary bypass	urinary NGAL
fluid management	intraoperative (from anesthetic induction to end of surgery)	blood loss
myocardial injury	intraoperative (before skin incision, end of cardiopulmonary bypass), 4 hours after end of surgery, 24 hours after end of surgery	level of Troponin i
anesthesia monitoring	intraoperative (from anesthetic induction to end of surgery)	Bispectral index, end tidal sevoflurane

Trial Locations

Locations (1)

Seoul national university hospital; 🇰🇷 Seoul, Korea, Republic of