Dexmedetomidine and Neuroprotection in Children Undergoing General Anesthesia

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

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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