ED50 of Dexmedetomidine to Prevent Emergence Agitation in... | NCT01374737

Studies
ED50 of Dexmedetomidine to Prevent Emergence Agitation in Children

NCT01374737

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Jun 16, 2011Estimated

Enrollment

25Estimated

Phase

Phase 4

Conditions

Agitation

Interventions

Dexmedetomidine

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

Jun 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Dec 2011Estimated

Completion Date

Feb 2012Estimated

First Submitted Date

Jun 9, 2011

First Submission Date that Met QC Criteria

Jun 15, 2011

First Posted Date

Jun 16, 2011Estimated

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

Jun 15, 2011

Last Update Posted Date

Jun 16, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

There are several recommended doses of dexmedetomidine for prevention of emergence agitation in children. In this study, the investigators examine ED50 in prevention of emergence agitation after tonsillectomy or adenoidectomy in children.

Detailed Description

To investigate ED50, Dixon's up and down method will be used.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
dexmedetomidine, children	Other		Drug: Dexmedetomidine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexmedetomidine	Drug	dexmedetomidine, 0.1ug/kg up or down	dexmedetomidine, children

Measure	Description	Time Frame
agitation		30 minutes

Measure	Description	Time Frame
pain		30 minutes

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

tonsillectomy or adenoidectomy

Exclusion Criteria:

recent URI

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hee-Soo Kim, M.D., PhD	Contact	82220723659		dami0605@snu.ac.kr

Overall Officials

Name	Affiliation	Role
Hee-Soo Kim, M.D, PhD	Seoul National University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SNUH	Recruiting	Seoul		110744	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D011595	Psychomotor Agitation

Ancestor Terms

ID	Term
D020820	Dyskinesias
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D011596	Psychomotor Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

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