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

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ClinicalTrials.gov Identifier: NCT01578161
Recruitment Status : Unknown
Verified April 2012 by Ah-Young Oh, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : April 16, 2012
Last Update Posted : April 16, 2012
Sponsor:
Information provided by (Responsible Party):
Ah-Young Oh, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE April 13, 2012
First Posted Date  ICMJE April 16, 2012
Last Update Posted Date April 16, 2012
Study Start Date  ICMJE January 2012
Estimated Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2012)
Agitation score [ Time Frame: 30 mins after operation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2012)
Oculomotor reflex [ Time Frame: Intraoperative ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Dexmedetomidine on Emergence Agitation in Children Undergoing a Surgery Under Desflurane Anesthesia
Official Title  ICMJE The Effect of Dexmedetomidine on Emergence Agitation in Children Undergoing a Surgery Under Desflurane Anesthesia
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Psychomotor Agitation
Intervention  ICMJE
  • 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 Name: Precedex
  • Drug: 0.9% Normal Saline
    Placebo,Normal saline 10ml ivs. for 10min.
Study Arms  ICMJE
  • Experimental: Dexmedetomidine0.25
    dexmedetomidine 0.25 microg.kg(-1),(Group D0.25) ivs. for 10min.
    Intervention: Drug: Dexmedetomidine
  • Experimental: Dexmedetomidine0.5
    dexmedetomidine 0.5 microg.kg(-1),(group D0.5) ivs. for 10min.
    Intervention: Drug: Dexmedetomidine
  • Experimental: Dexmedetomidine1.0
    dexmedetomidine 1 microg.kg(-1) ivs. for 10min.
    Intervention: Drug: Dexmedetomidine
  • Placebo Comparator: NormalSaline
    Normal saline 10ml ivs. for 10min.
    Intervention: Drug: 0.9% Normal Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 13, 2012)
116
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2013
Estimated Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01578161
Other Study ID Numbers  ICMJE SNUBH_01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ah-Young Oh, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: AhYoung Oh Seoul National University Bundang Hospital
PRS Account Seoul National University Hospital
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP