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The Effect of Dexmedetomidine on Emergence Agitation in Children Undergoing a Surgery Under Desflurane Anesthesia

Primary Purpose

Psychomotor Agitation

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexmedetomidine
0.9% Normal Saline
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Psychomotor Agitation

Eligibility Criteria

2 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Physical status classification of American Society of Anesthesiologist 1-2,
  • Healthy, normal
  • 2-6 years old
  • Elective operation

Exclusion Criteria:

  • Lack of consent
  • Known adverse effects to dexmedetomidine, mental retardation
  • Developmental delay, or neurological or psychiatric illness that may associate with agitation (cerebral palsy, seizure, etc)
  • No cardiac disease

Sites / Locations

  • Department of Anesthesiology and Pain Medicine, SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITALRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Dexmedetomidine0.25

Dexmedetomidine0.5

Dexmedetomidine1.0

NormalSaline

Arm Description

dexmedetomidine 0.25 microg.kg(-1),(Group D0.25) ivs. for 10min.

dexmedetomidine 0.5 microg.kg(-1),(group D0.5) ivs. for 10min.

dexmedetomidine 1 microg.kg(-1) ivs. for 10min.

Normal saline 10ml ivs. for 10min.

Outcomes

Primary Outcome Measures

Agitation score

Secondary Outcome Measures

Oculomotor reflex

Full Information

First Posted
April 13, 2012
Last Updated
April 13, 2012
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01578161
Brief Title
The Effect of Dexmedetomidine on Emergence Agitation in Children Undergoing a Surgery Under Desflurane Anesthesia
Official Title
The Effect of Dexmedetomidine on Emergence Agitation in Children Undergoing a Surgery Under Desflurane Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
April 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
After genernal anesthesia using sevoflurane or desflurane, the investigators can observe many cases of agiation (over 80%) and despite of no report of long-term complication, agitation is a big issue in PACU for doctors and nurses. The investigators use dexmedetomidine for prevention of agiation of preschool aged children. The investigators expect single injection of dexmedetomidine lead to decrease postoperative agitation and pain without any complication like oculocardiac reflex requiring atopine for treatment.
Detailed Description
There are four groups accoding to dosage of dexmedetomidine. Dexmedetomidine 0.25 microg.kg(-1),(group D0.25), dexmedetomidine 0.5 microg.kg(-1),(Group D0.5), dexmedetomidine 1 microg.kg(-1) (Group D 1) and normal saline(group P) is administered ivs. for 10mins when we are inducing each patient.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychomotor Agitation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine0.25
Arm Type
Experimental
Arm Description
dexmedetomidine 0.25 microg.kg(-1),(Group D0.25) ivs. for 10min.
Arm Title
Dexmedetomidine0.5
Arm Type
Experimental
Arm Description
dexmedetomidine 0.5 microg.kg(-1),(group D0.5) ivs. for 10min.
Arm Title
Dexmedetomidine1.0
Arm Type
Experimental
Arm Description
dexmedetomidine 1 microg.kg(-1) ivs. for 10min.
Arm Title
NormalSaline
Arm Type
Placebo Comparator
Arm Description
Normal saline 10ml ivs. for 10min.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
There are four groups accoding to dosage of dexmedetomidine. Dexmedetomidine 0.25 microg.kg(-1),(group D0.25), dexmedetomidine 0.5 microg.kg(-1),(Group D0.5), dexmedetomidine 1 microg.kg(-1) (Group D 1) and normal saline(group P) is administered ivs. for 10mins when we are inducing each patient.
Intervention Type
Drug
Intervention Name(s)
0.9% Normal Saline
Intervention Description
Placebo,Normal saline 10ml ivs. for 10min.
Primary Outcome Measure Information:
Title
Agitation score
Time Frame
30 mins after operation
Secondary Outcome Measure Information:
Title
Oculomotor reflex
Time Frame
Intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Physical status classification of American Society of Anesthesiologist 1-2, Healthy, normal 2-6 years old Elective operation Exclusion Criteria: Lack of consent Known adverse effects to dexmedetomidine, mental retardation Developmental delay, or neurological or psychiatric illness that may associate with agitation (cerebral palsy, seizure, etc) No cardiac disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
INAE SONG
Phone
82-10-2609-2401
Email
nodame1@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AhYoung Oh
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL
City
SungNam-si
State/Province
Kyonggi do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SangHwan Do
Phone
82-31-787-7499
Email
shdo@snubh.org
First Name & Middle Initial & Last Name & Degree
AhYoung Oh

12. IPD Sharing Statement

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The Effect of Dexmedetomidine on Emergence Agitation in Children Undergoing a Surgery Under Desflurane Anesthesia

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