Dexmedetomidine Neuroprotection in Pediatric Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-25

Study Completion Date

2023-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Congenital Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dexmedetomidine

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

continuous infusion of dexmedetomidine during the surgery

Control

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

continuous infusion of normal saline during the surgery

Interventions

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Dexmedetomidine

continuous infusion of dexmedetomidine during the surgery

Intervention Type DRUG

Normal saline

continuous infusion of normal saline during the surgery

Intervention Type DRUG

Eligibility Criteria

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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

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No