The Effect of Dexmedetomidine on Decreasing Emergence Agitation and Delirium in Pediatric Patients Undergoing Strabismus Surgery
Primary Purpose
Strabismus
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexmedetomidine
placebo group
Sponsored by
About this trial
This is an interventional treatment trial for Strabismus
Eligibility 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
Sites / Locations
- Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
dexmedetomidine
placebo
Arm Description
Outcomes
Primary Outcome Measures
objective pain score
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
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
3. Scoring system for emergence agitation (behavior score)
Sleeping
Awake and calm
Irritable and crying
Inconsolable crying
Severe restlessness and disorientation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01512355
Brief Title
The Effect of Dexmedetomidine on Decreasing Emergence Agitation and Delirium in Pediatric Patients Undergoing Strabismus Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Strabismus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dexmedetomidine
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
After, induction of general anesthesia, dexmedetomidine 0.2 mcg/kg/hr continuous intravenous infused during the surgery
Intervention Type
Drug
Intervention Name(s)
placebo group
Intervention Description
normal saline_02mcg/kg/hr
Primary Outcome Measure Information:
Title
objective pain score
Description
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
Time Frame
immediate postoperative period up to 1hour after surgery
Title
pediatric anesthesia emergence delirium (PAED) scale
Description
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
Time Frame
immediate postoperative period up to 1hour after surgery
Title
5-point agitation scale
Description
3. Scoring system for emergence agitation (behavior score)
Sleeping
Awake and calm
Irritable and crying
Inconsolable crying
Severe restlessness and disorientation
Time Frame
immediate postoperative period up to 1hour after surgery
10. Eligibility
Sex
All
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Effect of Dexmedetomidine on Decreasing Emergence Agitation and Delirium in Pediatric Patients Undergoing Strabismus Surgery
We'll reach out to this number within 24 hrs