Dexmedetomidine and Neuroprotection in Children Undergoing General Anesthesia

Dexmedetomidine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03234660
• Other study ID #: H1706-132-861
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: October 5, 2019

Study information

• Verified date: December 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

GFAP measure

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 5, 2019
• Est. primary completion date: October 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 3 Years

Eligibility

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)

Related Conditions & MeSH terms

• Dexmedetomidine

Intervention

Drug:
• Dexmedetomidine Hydrochloride
dexmedetomidine 1mcg/kg loading and 0.5mcg/kg/hr continuous infusion during surgery

Other:
• control
0.9% normal saline continuous infusion

Locations

Country	Name	City	State
Korea, Republic of	SNUH	Seoul	Jongro Gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glial fibrillary acid protein	plasma was collected at the given specific time	change from baseline glial fibrillary acid protein at 3 hours after the anesthetic induction