Back to resultsEffect of Dexmedetomidine on Sevoflurane Requirements and Emergence Agitation in Children Undergoing Ambulatory Surgery
Primary Purpose
Ambulation Difficulty
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexmedetomidine
normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Ambulation Difficulty
Eligibility Criteria
Inclusion Criteria:
- ASA class I
- obtaining written informed consent from the parents
- aged 1-5 years, and weighing <20 kg who were undergoing ambulatory hernioplasty or orchiopexy
Exclusion Criteria:
- mental retardation
- developmental delays
- neurological or psychiatric illnesses
- coagulation disorder
- spinal anomalies
- bilateral procedures
Sites / Locations
- Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
dexmedetomidine
placebo group
Arm Description
normal saline
Outcomes
Primary Outcome Measures
the reduction rate of ET-sevo in achieving BIS scores from 45-50
Secondary Outcome Measures
Full Information
NCT ID
NCT01691001
First Posted
September 12, 2012
Last Updated
September 18, 2012
Sponsor
Yonsei University
1. Study Identification
Unique Protocol Identification Number
NCT01691001
Brief Title
Effect of Dexmedetomidine on Sevoflurane Requirements and Emergence Agitation in Children Undergoing Ambulatory Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
August 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
Although the aetiology of emergence agitation (EA) derives from multiple factors, it is a frequent side effect of sevoflurane anaesthesia in children. Dexmedetomidine, a potent selective α2-adrenergic agonist, can reduce the doses of hypnotics, opioids, analgesics, and anaesthetics that must be concomitantly administered. This study was conducted to assess the effect of dexmedetomidine infusion on sevoflurane requirements and recovery profiles with EA in children undergoing ambulatory surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ambulation Difficulty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dexmedetomidine
Arm Type
Experimental
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
normal saline
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
dexmedetomidine(vs saline) 1 mcg/kg iv bolus during 10minutes, and then, 0.1 mcg/kg/h dexmedetomidine(vs saline) was infused.
Intervention Type
Drug
Intervention Name(s)
normal saline
Primary Outcome Measure Information:
Title
the reduction rate of ET-sevo in achieving BIS scores from 45-50
Time Frame
2 hour(during whole operation period)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA class I
obtaining written informed consent from the parents
aged 1-5 years, and weighing <20 kg who were undergoing ambulatory hernioplasty or orchiopexy
Exclusion Criteria:
mental retardation
developmental delays
neurological or psychiatric illnesses
coagulation disorder
spinal anomalies
bilateral procedures
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
Effect of Dexmedetomidine on Sevoflurane Requirements and Emergence Agitation in Children Undergoing Ambulatory Surgery
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