The Effect of Dexmedetomidine on Emergence Agitation in Children Undergoing a Surgery Under Desflurane Anesthesia

NCT ID: NCT01578161

Last Updated: 2012-04-16

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-04-30

Brief Summary

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After genernal anesthesia using sevoflurane or desflurane, the investigators can observe many cases of agiation (over 80%) and despite of no report of long-term complication, agitation is a big issue in PACU for doctors and nurses. The investigators use dexmedetomidine for prevention of agiation of preschool aged children. The investigators expect single injection of dexmedetomidine lead to decrease postoperative agitation and pain without any complication like oculocardiac reflex requiring atopine for treatment.

Detailed Description

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There are four groups accoding to dosage of dexmedetomidine. Dexmedetomidine 0.25 microg.kg(-1),(group D0.25), dexmedetomidine 0.5 microg.kg(-1),(Group D0.5), dexmedetomidine 1 microg.kg(-1) (Group D 1) and normal saline(group P) is administered ivs. for 10mins when we are inducing each patient.

Conditions

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Psychomotor Agitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Dexmedetomidine0.25

dexmedetomidine 0.25 microg.kg(-1),(Group D0.25) ivs. for 10min.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

There are four groups accoding to dosage of dexmedetomidine. Dexmedetomidine 0.25 microg.kg(-1),(group D0.25), dexmedetomidine 0.5 microg.kg(-1),(Group D0.5), dexmedetomidine 1 microg.kg(-1) (Group D 1) and normal saline(group P) is administered ivs. for 10mins when we are inducing each patient.

Dexmedetomidine0.5

dexmedetomidine 0.5 microg.kg(-1),(group D0.5) ivs. for 10min.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

There are four groups accoding to dosage of dexmedetomidine. Dexmedetomidine 0.25 microg.kg(-1),(group D0.25), dexmedetomidine 0.5 microg.kg(-1),(Group D0.5), dexmedetomidine 1 microg.kg(-1) (Group D 1) and normal saline(group P) is administered ivs. for 10mins when we are inducing each patient.

Dexmedetomidine1.0

dexmedetomidine 1 microg.kg(-1) ivs. for 10min.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

There are four groups accoding to dosage of dexmedetomidine. Dexmedetomidine 0.25 microg.kg(-1),(group D0.25), dexmedetomidine 0.5 microg.kg(-1),(Group D0.5), dexmedetomidine 1 microg.kg(-1) (Group D 1) and normal saline(group P) is administered ivs. for 10mins when we are inducing each patient.

NormalSaline

Normal saline 10ml ivs. for 10min.

Group Type PLACEBO_COMPARATOR

0.9% Normal Saline

Intervention Type DRUG

Placebo,Normal saline 10ml ivs. for 10min.

Interventions

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Dexmedetomidine

There are four groups accoding to dosage of dexmedetomidine. Dexmedetomidine 0.25 microg.kg(-1),(group D0.25), dexmedetomidine 0.5 microg.kg(-1),(Group D0.5), dexmedetomidine 1 microg.kg(-1) (Group D 1) and normal saline(group P) is administered ivs. for 10mins when we are inducing each patient.

Intervention Type DRUG

0.9% Normal Saline

Placebo,Normal saline 10ml ivs. for 10min.

Intervention Type DRUG

Other Intervention Names

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Precedex

Eligibility Criteria

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Inclusion Criteria

* Physical status classification of American Society of Anesthesiologist 1-2,
* Healthy, normal
* 2-6 years old
* Elective operation

Exclusion Criteria

* Lack of consent
* Known adverse effects to dexmedetomidine, mental retardation
* Developmental delay, or neurological or psychiatric illness that may associate with agitation (cerebral palsy, seizure, etc)
* No cardiac disease
Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ah-Young Oh

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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AhYoung Oh

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Department of Anesthesiology and Pain Medicine, SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL

SungNam-si, Kyonggi Do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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INAE SONG

Role: CONTACT

82-10-2609-2401

Facility Contacts

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SangHwan Do

Role: primary

82-31-787-7499

Other Identifiers

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SNUBH_01

Identifier Type: -

Identifier Source: org_study_id

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