Emergence Agitation in Pediatric Strabismus Surgery

NCT ID: NCT03807011

Last Updated: 2019-01-23

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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-07

Study Completion Date

2018-10-05

Brief Summary

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This study was performed to assess the effects of continuous remifentanil infusion and single bolus administration of fentanyl on the incidence of emergence agitation in pediatrics undergoing strabismus surgery.

Detailed Description

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Conditions

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Emergence Agitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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fentanyl

A bolus dose of fentanyl 2 μg/kg was administered intravenously at anesthetic induction

Group Type ACTIVE_COMPARATOR

fentanyl group

Intervention Type DRUG

fentanyl 2 μg/kg

remifentanil

Remifentanil was continuously infused at a rate of 0.2 μg/kg/min from anesthetic induction to the end of surgery

Group Type ACTIVE_COMPARATOR

remifentanil group

Intervention Type DRUG

remifentanil 0.2 μg/kg/min

Interventions

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fentanyl group

fentanyl 2 μg/kg

Intervention Type DRUG

remifentanil group

remifentanil 0.2 μg/kg/min

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients undergoing elective subumbilical surgery,
* physical status was American Society of Anesthesiologists (ASA) class 1 or 2

Exclusion Criteria

* history of airway problem,
* upper respiratory tract infection within 2 weeks,
* developmental delay,
* neurological or psychological disease,
* history of allergy to the drugs in our protocol were excluded in this study.
Minimum Eligible Age

2 Years

Maximum Eligible Age

8 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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Eun Kyung Choi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Eun kyung Choi

Daegu, Korea (the Republic Of), South Korea

Site Status

Yeungnam University Hospital

Daegu, Nam-gu, Daegu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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YUMC 2017-04-071

Identifier Type: -

Identifier Source: org_study_id

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