The Effect of Remifentanil Infusion During Emergence on the Incidence of Emergence Delirium

NCT ID: NCT02108795

Last Updated: 2015-07-16

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

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-05-31

Brief Summary

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The aim of the present study is to assess the effect of postoperative remifentanil infusion on the incidence of emergence agitation in preschool-aged children undergoing strabismus surgery with sevoflurane anaesthesia.

Detailed Description

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Patients are randomly assigned to one of two groups. Anesthesia is maintained with sevoflurane and remifentanil infusion. All patients received a predetermined concentrations of remifentanil according to their group assignments (control group, remifentanil 0 ug/kg/min; remifentanil group, remifentanil 0.05 ug/kg/min) from 10 minutes before the end of surgery to discharge from postanesthetic care unit. emergence agitation is assessed during the emergence phase.

Conditions

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Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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remifentanil group

Remifentanil 0.05 ug/kg/min is infused to the patients.

Group Type EXPERIMENTAL

Remifentanil

Intervention Type DRUG

Children randomised to remifentanil group receive remifentanil 0.05 ug/kg/min. Children randomised to control group receive normal saline (placebo)

control

Normal saline 0.2 ml/kg/hour is infused to the patients

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Remifentanil

Children randomised to remifentanil group receive remifentanil 0.05 ug/kg/min. Children randomised to control group receive normal saline (placebo)

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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remifentanil (ultiva)

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists physical status I and II
* preschool-aged children undergoing strabismus surgery

Exclusion Criteria

* psychological disorders
* emotional disorders
* abnormal cognitive development
* developmental delay
* allergy to the drugs in our protocol
Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yeungnam University College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Sangjin Park

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sangjin Park, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology and Pain Medicine, College of medicine, Yeungnam University, Daemyung-Dong, Nam-Gu, Daegu, Republic of Korea

Locations

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Department of Anesthesiology and Pain Medicine, Yeungnam University hospital

Daegu, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Sangjin Park, M.D.

Role: CONTACT

82-53-620-3366

Facility Contacts

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Duckhee Lee, M.D.

Role: primary

82-53-620-3365

Other Identifiers

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apsj20140331

Identifier Type: -

Identifier Source: org_study_id

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