Back to resultsED50 of Dexmedetomidine to Prevent Emergence Agitation in Children
Primary Purpose
Agitation
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexmedetomidine
Sponsored by
About this trial
This is an interventional prevention trial for Agitation
Eligibility Criteria
Inclusion Criteria:
- tonsillectomy or adenoidectomy
Exclusion Criteria:
- recent URI
Sites / Locations
- SNUHRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
dexmedetomidine, children
Arm Description
Outcomes
Primary Outcome Measures
agitation
Secondary Outcome Measures
pain
Full Information
NCT ID
NCT01374737
First Posted
June 9, 2011
Last Updated
June 15, 2011
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01374737
Brief Title
ED50 of Dexmedetomidine to Prevent Emergence Agitation in Children
Official Title
ED50 of Dexmedetomidine for Reduction of Emergence Agitation Incidence Undergoing Tonsillectomy or Adenoidectomy in Desflurane Anesthesia Following Sevoflurane Induction in Children
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
February 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
dexmedetomidine, children
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
precedex
Intervention Description
dexmedetomidine, 0.1ug/kg up or down
Primary Outcome Measure Information:
Title
agitation
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
pain
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
tonsillectomy or adenoidectomy
Exclusion Criteria:
recent URI
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hee-Soo Kim, M.D., PhD
Phone
82220723659
Email
dami0605@snu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee-Soo Kim, M.D, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
SNUH
City
Seoul
ZIP/Postal Code
110744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hee-Soo Kim, M.D., PhD
Phone
82220723659
Email
dami0605@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Hyo-Jin Byon, M.D.
12. IPD Sharing Statement
Learn more about this trial
ED50 of Dexmedetomidine to Prevent Emergence Agitation in Children
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