NCT03234660

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 31, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2019

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

2.1 years

First QC Date

July 17, 2017

Last Update Submit

December 29, 2019

Conditions

Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

dexmedetomidine infusion

Drug: Dexmedetomidine Hydrochloride

control

PLACEBO COMPARATOR

placebo infusion

Other: control

Interventions

Dexmedetomidine HydrochlorideDRUG

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

Dexmedetomidine
controlOTHER

0.9% normal saline continuous infusion

control

Eligibility Criteria

Age1 Month - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children undergoing general anesthesia longer than 3 hours

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SNUH

Seoul, Jongro Gu, 15710, South Korea

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 17, 2017

First Posted

July 31, 2017

Study Start

September 1, 2017

Primary Completion

October 5, 2019

Study Completion

October 5, 2019

Last Updated

January 2, 2020

Record last verified: 2019-12

Locations

KR(1)