Emergency Agitation in T&A

NCT ID: NCT01152476

Last Updated: 2011-01-06

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

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-10-31

Brief Summary

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Sevoflurane has been used commonly in pediatric anesthesia since 1990. However, it has caused more emergency agitation (EA) that other inhalation agents and the incidence is up to 80%. Therefore, lower minimum alveolar concentration of sevoflurane will reduce the EA when it is used with remifentanil in pediatric general anesthesia.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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group SR

Group Type ACTIVE_COMPARATOR

remifentanil

Intervention Type DRUG

General anesthesia is maintained witn sevoflurane and remifentanil.

group S

Group Type ACTIVE_COMPARATOR

normal saline

Intervention Type DRUG

General anesthesia is maintained with only sevoflurane and with normal saline instead of remifentanil

Interventions

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remifentanil

General anesthesia is maintained witn sevoflurane and remifentanil.

Intervention Type DRUG

normal saline

General anesthesia is maintained with only sevoflurane and with normal saline instead of remifentanil

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologist physical status I or II
* 2-6 year-old children
* patients undergoing tonsillectomy and adenoidectomy

Exclusion Criteria

* upper respiratory disease
* mental retardation
Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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T&A_EA

Identifier Type: -

Identifier Source: org_study_id

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