Effect of Dexmedetomidine on Sevoflurane Requirements and... | NCT01691001

Studies
Effect of Dexmedetomidine on Sevoflurane Requirements and Emergence Agitation in Children Undergoing Ambulatory Surgery

NCT01691001

Sponsor

Yonsei University

Status

Completed

Last Update Posted

Sep 24, 2012Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Ambulation Difficulty

Interventions

Dexmedetomidine
normal saline

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Mar 2012Actual

Completion Date

Mar 2012Actual

First Submitted Date

Sep 12, 2012

First Submission Date that Met QC Criteria

Sep 18, 2012

First Posted Date

Sep 24, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2012

Last Update Posted Date

Sep 24, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
dexmedetomidine	Experimental		Drug: Dexmedetomidine
placebo group	Placebo Comparator	normal saline	Drug: normal saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexmedetomidine	Drug	dexmedetomidine(vs saline) 1 mcg/kg iv bolus during 10minutes, and then, 0.1 mcg/kg/h dexmedetomidine(vs saline) was infused.	dexmedetomidine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the reduction rate of ET-sevo in achieving BIS scores from 45-50		2 hour(during whole operation period)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

5 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Severance Hospital		Seoul	Seoul	120-752	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D051346	Mobility Limitation

Ancestor Terms

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020927	Dexmedetomidine
D000077330	Saline Solution

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided