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The Effect of Dexmedetomidine on Decreasing Emergence Agitation and Delirium in Pediatric Patients Undergoing Strabismus Surgery

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. Identifier: NCT01512355
Recruitment Status : Completed
First Posted : January 19, 2012
Last Update Posted : July 16, 2015
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
Postoperative agitation in children is a well-documented clinical phenomenon with incidence ranging from 10% to 67%. Recently, dexmedetomidine has been investigated extensively in the pediatric population and there is now increasing evidence to support the use of this drug as sedative and anesthetic adjunct in children. The purpose of this study is to determine whether prophylactic use of intraoperative dexmedetomidine to prevent of emergence delirium.

Condition or disease Intervention/treatment Phase
Strabismus Drug: Dexmedetomidine Drug: placebo group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Experimental: dexmedetomidine Drug: Dexmedetomidine
After, induction of general anesthesia, dexmedetomidine 0.2 mcg/kg/hr continuous intravenous infused during the surgery

Placebo Comparator: placebo Drug: placebo group
normal saline_02mcg/kg/hr

Primary Outcome Measures :
  1. objective pain score [ Time Frame: immediate postoperative period up to 1hour after surgery ]
    1. Objective pain score(OPS) Blood pressure 0~2 points crying 0~2points movement 0~2points agitation 0~2points posture 0~2points complain of pain(where appropiraate by age) 0~2points total 0~10 points

  2. pediatric anesthesia emergence delirium (PAED) scale [ Time Frame: immediate postoperative period up to 1hour after surgery ]
    2. pediatric anesthesia emergence delirium (PAED) scale The Child makes eye contact with the caregiver 0~4 The child's actions are purposeful. 0~4 The child is aware of his'her surroundings. 0~4 The child is restless. 0~4 The child is insonsolable. 0~4 total 0~20 points

  3. 5-point agitation scale [ Time Frame: immediate postoperative period up to 1hour after surgery ]

    3. Scoring system for emergence agitation (behavior score)

    1. Sleeping
    2. Awake and calm
    3. Irritable and crying
    4. Inconsolable crying
    5. Severe restlessness and disorientation

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • the patient undergoing the strabismus surgery in severance hospital

Exclusion Criteria:

  • delayed development
  • mental retardation
  • cerebral palsy
  • preoperative EKG abnormality e.g. cardiovascular conduction disorder

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 identifier (NCT number): NCT01512355

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Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University Identifier: NCT01512355     History of Changes
Other Study ID Numbers: 4-2011-0466
First Posted: January 19, 2012    Key Record Dates
Last Update Posted: July 16, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
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