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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Yonsei University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01512355
First received: January 9, 2012
Last updated: January 13, 2012
Last verified: January 2012
  Purpose

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 Intervention
Strabismus
Drug: Dexmedetomidine
Drug: placebo group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • objective pain score [ Time Frame: immediate postoperative period up to 1hour after surgery ] [ Designated as safety issue: No ]
    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

  • pediatric anesthesia emergence delirium (PAED) scale [ Time Frame: immediate postoperative period up to 1hour after surgery ] [ Designated as safety issue: No ]
    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

  • 5-point agitation scale [ Time Frame: immediate postoperative period up to 1hour after surgery ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 88
Study Start Date: September 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01512355

Contacts
Contact: Bon-Nyeo Koo, MD 82-2-2228-2420 koobn@yuhs.ac
Contact: Jeong-Min Kim, MD 82-2-2228-2420 ANESJEONGMIN@yuhs.ac

Locations
Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Bon-nyeo Koo, MD    82-2-2228-2420    koobn@yuhs.ac   
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01512355     History of Changes
Other Study ID Numbers: 4-2011-0466
Study First Received: January 9, 2012
Last Updated: January 13, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Ocular Motility Disorders
Strabismus
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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 August 27, 2014