Dexmedetomidine and Neuroprotection in Children Undergoin... | NCT03234660

Studies
Dexmedetomidine and Neuroprotection in Children Undergoing General Anesthesia

NCT03234660

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Jan 2, 2020Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Dexmedetomidine

Interventions

Dexmedetomidine Hydrochloride
control

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Actual

Primary Completion Date

Oct 5, 2019Actual

Completion Date

Oct 5, 2019Actual

First Submitted Date

Jul 17, 2017

First Submission Date that Met QC Criteria

Jul 28, 2017

First Posted Date

Jul 31, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 29, 2019

Last Update Posted Date

Jan 2, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

GFAP measure

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dexmedetomidine	Experimental	dexmedetomidine infusion	Drug: Dexmedetomidine Hydrochloride
control	Placebo Comparator	placebo infusion	Other: control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexmedetomidine Hydrochloride	Drug	dexmedetomidine 1mcg/kg loading and 0.5mcg/kg/hr continuous infusion during surgery	Dexmedetomidine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

3 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SNUH		Seoul	Jongro Gu	15710	South Korea

Intervention Browse Module

MeSH Terms

ID	Term
D020927	Dexmedetomidine

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided