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Dexmedetomidine and Neuroprotection in Children Undergoing General Anesthesia

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Seoul National University

Status

Completed

Conditions

Dexmedetomidine

Treatments

Other: control
Drug: Dexmedetomidine Hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT03234660
H1706-132-861

Details and patient eligibility

About

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.

Full description

GFAP measure

Enrollment

60 patients

Sex

All

Ages

1 month to 3 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

60 participants in 2 patient groups, including a placebo group

Dexmedetomidine
Experimental group
Description:
dexmedetomidine infusion
Treatment:
Drug: Dexmedetomidine Hydrochloride
control
Placebo Comparator group
Description:
placebo infusion
Treatment:
Other: control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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