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

This study is currently recruiting participants.
Verified April 2012 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Ah-Young Oh, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01578161
First received: April 13, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
  Purpose

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 Intervention Phase
Psychomotor Agitation
 Drug: Dexmedetomidine
Drug: 0.9% Normal Saline
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Dexmedetomidine on Emergence Agitation in Children Undergoing a Surgery Under Desflurane Anesthesia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Agitation score [ Time Frame: 30 mins after operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Oculomotor reflex [ Time Frame: Intraoperative ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 116
Study Start Date: January 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Precedex
Placebo Comparator: NormalSaline
Normal saline 10ml ivs. for 10min.
 Drug: 0.9% Normal Saline
Placebo,Normal saline 10ml ivs. for 10min.

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.

  Eligibility

Ages Eligible for Study:   2 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578161

Contacts
Contact: INAE SONG 82-10-2609-2401 nodame1@naver.com

Locations
Korea, Republic of
Department of Anesthesiology and Pain Medicine, SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL Recruiting
SungNam-si, Kyonggi do, Korea, Republic of, 463-707
Contact: SangHwan Do     82-31-787-7499     shdo@snubh.org    
Principal Investigator: AhYoung Oh            
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: AhYoung Oh Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Ah-Young Oh, Assistant Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01578161     History of Changes
Other Study ID Numbers: SNUBH_01
Study First Received: April 13, 2012
Last Updated: April 13, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Psychomotor Agitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Anesthetics
Desflurane
Dexmedetomidine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Anesthetics, Inhalation
Anesthetics, General
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013