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

Sponsor
Seoul National University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01578161
Collaborator
(none)
116
Enrollment
1
Location
4
Arms
15
Duration (Months)
7.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
116 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
The Effect of Dexmedetomidine on Emergence Agitation in Children Undergoing a Surgery Under Desflurane Anesthesia
Study Start Date :
Jan 1, 2012
Anticipated Primary Completion Date :
Jan 1, 2013
Anticipated Study Completion Date :
Apr 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dexmedetomidine0.25

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

Drug: Dexmedetomidine
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.
Other Names:
  • Precedex

    		•
    Experimental: Dexmedetomidine0.5

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

    Drug: Dexmedetomidine
    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.
    Other Names:
  • Precedex

    		•
    Experimental: Dexmedetomidine1.0

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

    Drug: Dexmedetomidine
    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.
    Other Names:
  • Precedex

    		•
    Placebo Comparator: NormalSaline

    Normal saline 10ml ivs. for 10min.

    Drug: 0.9% Normal Saline
    Placebo,Normal saline 10ml ivs. for 10min.

    Outcome Measures

    Primary Outcome Measures

    1. Agitation score [30 mins after operation]

    Secondary Outcome Measures

    1. Oculomotor reflex [Intraoperative]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 6 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anesthesiology and Pain Medicine, SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL SungNam-si Kyonggi do Korea, Republic of 463-707

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Principal Investigator: AhYoung Oh, Seoul National University Bundang Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ah-Young Oh, Assistant Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT01578161
    Other Study ID Numbers:
    • SNUBH_01
    First Posted:
    Apr 16, 2012
    Last Update Posted:
    Apr 16, 2012
    Last Verified:
    Apr 1, 2012
    Additional relevant MeSH terms:
    Psychomotor Agitation
    Emergence Delirium
    Dexmedetomidine

    Study Results

    No Results Posted as of Apr 16, 2012