Dexmedetomidine Neuroprotection in Pediatric Cardiac Surgery

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04484922
• Other study ID #: 2001-062-1095
• Status: Recruiting
• Phase: N/A
• Start date: August 25, 2020
• Est. completion date: May 31, 2023

Study information

• Verified date: February 2022
• Source: Seoul National University Hospital
• Contact: Eun-hee Kim
• Phone: +82-01-9933-5014
• Email: beloveun[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Year

Eligibility

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)

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Drug:
• Dexmedetomidine
continuous infusion of dexmedetomidine during the surgery
• Normal saline
continuous infusion of normal saline during the surgery

Locations

Country	Name	City	State
Korea, Republic of	Seoul national university hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bayley scales of Infant development	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)	1 year after the surgery
Secondary	neurodevelopment biomarker	plasma glial fibrillary acidic protein concentration	intraoperative (before skin incision, end of hypothermia, end of cardiopulmonary bypass), 4 hours after end of surgery
Secondary	inflammation	level of IL-6	4 hours after end of surgery
Secondary	acute kidney injury	urinary NGAL	2 hours after end of cardiopulmonary bypass
Secondary	myocardial injury	level of Troponin i	intraoperative (before skin incision, end of cardiopulmonary bypass), 4 hours after end of surgery, 24 hours after end of surgery
Secondary	anesthesia monitoring	Bispectral index, end tidal sevoflurane	intraoperative (from anesthetic induction to end of surgery)
Secondary	fluid management	amount of transfusion, ROTEM® values	intraoperative (from anesthetic induction to end of surgery)
Secondary	fluid management	blood loss	intraoperative (from anesthetic induction to end of surgery)