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Dexmedetomidine and Neuroprotection in Children Undergoing General Anesthesia

The Effects of Dexmedetomidine on the Neurotoxicity From General Anesthesia Assessed by Plasma Glial Fibrillary Acidic Protein

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03234660
Enrollment
60
Registered
2017-07-31
Start date
2017-09-01
Completion date
2019-10-05
Last updated
2020-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dexmedetomidine

Brief summary

Neuroapoptosis is induced by the administration of anesthetic agents to the young brain. Recent studies showed that the a2-adrenoceptor agonist, dexmedetomidine plays a trophic role during development and is neuroprotective in several settings of neuronal injury in animals. We hypothesized that neuroprotective effect of dexmedetomidine would be associated with evidence of brain injury detected by elevation of plasma concentration of glial fibrillary acid protein in children undergoing general anesthesia.

Detailed description

GFAP measure

Interventions

DRUGDexmedetomidine Hydrochloride

dexmedetomidine 1mcg/kg loading and 0.5mcg/kg/hr continuous infusion during surgery

OTHERcontrol

0.9% normal saline continuous infusion

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Months to 3 Years
Healthy volunteers
No

Inclusion criteria

* children undergoing general anesthesia longer than 3 hours

Exclusion criteria

* past history of anesthesia * cardiopulmonary bypass * preexisting neurocognitive dysfunction * abnormalities of liver profile (aspartate transaminase \> 40 unit/L, alanine aminotransferase \> 40 unit/L)

Design outcomes

Primary

MeasureTime frameDescription
Glial fibrillary acid proteinchange from baseline glial fibrillary acid protein at 3 hours after the anesthetic inductionplasma was collected at the given specific time

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026