---
title: Dexmedetomidine Neuroprotection in Pediatric Cardiac Surgery
nct_id: NCT04484922
overall_status: UNKNOWN
phase: NA
sponsor: Seoul National University Hospital
study_type: INTERVENTIONAL
primary_condition: Congenital Heart Disease
countries: South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04484922.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04484922"
ct_last_update_post_date: 2022-02-02
last_seen_at: "2026-05-12T07:08:55.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Dexmedetomidine Neuroprotection in Pediatric Cardiac Surgery

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

**NCT ID:** [NCT04484922](https://clinicaltrials.gov/study/NCT04484922)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 160
- **Lead Sponsor:** Seoul National University Hospital
- **Conditions:** Congenital Heart Disease
- **Start Date:** 2020-08-25
- **Completion Date:** 2023-05-31
- **CT.gov Last Update:** 2022-02-02

## 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.

## Eligibility

- **Maximum age:** 1 Year
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Dexmedetomidine** (EXPERIMENTAL)
- **Control** (PLACEBO_COMPARATOR)

## Interventions

- **Dexmedetomidine** (DRUG) — continuous infusion of dexmedetomidine during the surgery
- **Normal saline** (DRUG) — continuous infusion of normal saline during the surgery

## Primary Outcomes

- **Bayley scales of Infant development** _(time frame: 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 Outcomes

- **neurodevelopment biomarker** _(time frame: intraoperative (before skin incision, end of hypothermia, end of cardiopulmonary bypass), 4 hours after end of surgery)_
- **inflammation** _(time frame: 4 hours after end of surgery)_
- **acute kidney injury** _(time frame: 2 hours after end of cardiopulmonary bypass)_
- **myocardial injury** _(time frame: intraoperative (before skin incision, end of cardiopulmonary bypass), 4 hours after end of surgery, 24 hours after end of surgery)_
- **anesthesia monitoring** _(time frame: intraoperative (from anesthetic induction to end of surgery))_
- **fluid management** _(time frame: intraoperative (from anesthetic induction to end of surgery))_
- **fluid management** _(time frame: intraoperative (from anesthetic induction to end of surgery))_

## Locations (1)

- Seoul national university hospital, Seoul, South Korea — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.seoul national university hospital|seoul||south korea` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04484922.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04484922*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*