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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
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Strabismus

Eligibility Criteria

undefined - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

First Posted
January 9, 2012
Last Updated
July 15, 2015
Sponsor
Yonsei University
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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

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

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