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

NCT ID: NCT01691001

Last Updated: 2012-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-03-31

Brief Summary

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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

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Conditions

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Ambulation Difficulty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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dexmedetomidine

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

dexmedetomidine(vs saline) 1 mcg/kg iv bolus during 10minutes, and then, 0.1 mcg/kg/h dexmedetomidine(vs saline) was infused.

placebo group

normal saline

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

Interventions

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Dexmedetomidine

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

normal saline

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

5 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance Hospital

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2011-0430

Identifier Type: -

Identifier Source: org_study_id