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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2012 by Ah-Young Oh, Seoul National University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01578161
First Posted: April 16, 2012
Last Update Posted: April 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ah-Young Oh, Seoul National University Hospital
  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
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

Resource links provided by NLM:


Further study details as provided by Ah-Young Oh, Seoul National University Hospital:

Primary Outcome Measures:
  • Agitation score [ Time Frame: 30 mins after operation ]

Secondary Outcome Measures:
  • Oculomotor reflex [ Time Frame: Intraoperative ]

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

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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Ah-Young Oh, Assistant Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01578161     History of Changes
Other Study ID Numbers: SNUBH_01
First Submitted: April 13, 2012
First Posted: April 16, 2012
Last Update Posted: April 16, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Psychomotor Agitation
Emergence Delirium
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Delirium
Confusion
Postoperative Complications
Pathologic Processes
Neurocognitive Disorders
Mental Disorders
Dexmedetomidine
Desflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
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
Anesthetics, Inhalation