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OpenTrials
Completed

NCT Number: NCT03234660

Dexmedetomidine and Neuroprotection in Children Undergoing General Anesthesia

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.

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Key information

Conditions

Dexmedetomidine

Age range

1 month–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SNUH

Seoul, Jongro Gu, 15710, South Korea

About this study

GFAP measure

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dexmedetomidine Hydrochloride

Drug

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

Control

Other

0.9% normal saline continuous infusion

Primary outcomes

  1. Glial fibrillary acid protein

    Time frame: change from baseline glial fibrillary acid protein at 3 hours after the anesthetic induction

    plasma was collected at the given specific time

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 31, 2017
Registry last updated
Jan 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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