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Clinical Trials/NCT01578161
NCT01578161
Unknown
Phase 4

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

Seoul National University Hospital1 site in 1 country116 target enrollmentJanuary 2012

Overview

Phase
Phase 4
Intervention
Dexmedetomidine
Conditions
Psychomotor Agitation
Sponsor
Seoul National University Hospital
Enrollment
116
Locations
1
Primary Endpoint
Agitation score
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
April 2013
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ah-Young Oh

Assistant Professor

Seoul National University Hospital

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

Arms & Interventions

Dexmedetomidine0.25

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

Intervention: Dexmedetomidine

Dexmedetomidine0.5

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

Intervention: Dexmedetomidine

Dexmedetomidine1.0

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

Intervention: Dexmedetomidine

NormalSaline

Normal saline 10ml ivs. for 10min.

Intervention: 0.9% Normal Saline

Outcomes

Primary Outcomes

Agitation score

Time Frame: 30 mins after operation

Secondary Outcomes

  • Oculomotor reflex(Intraoperative)

Study Sites (1)

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