The Effect of Preoperative Ketamine on the Emergence Characteristics in Children Undergoing Entropion Surgery

NCT ID: NCT02916407

Last Updated: 2019-05-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-11-30

Brief Summary

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The investigators evaluate extubation time and recovery profiles in children undergoing entropion surgery.

Detailed Description

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This study will compare the extubation time and recovery profiles (degree of postoperative agitation and cough) between sevoflurane group and desflurane group. General anesthesia will maintained with sevoflurane 2-3vol% or desflurane 6-7vol%. After surgery, the investigators will measure the duration of extubation and recovery profiles between two groups.

Conditions

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Entropion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sevoflurane Group

The patients will maintained general anesthesia with sevoflurane.

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DRUG

Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children.

General anesthesia will maintained with sevoflurane 2-3 vol%.

Desflurane Group

The patients will maintained general anesthesia with desflurane.

Group Type EXPERIMENTAL

Desflurane

Intervention Type DRUG

Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children.

General anesthesia will maintained with desflurane 6-7vol%.

Interventions

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Sevoflurane

Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children.

General anesthesia will maintained with sevoflurane 2-3 vol%.

Intervention Type DRUG

Desflurane

Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children.

General anesthesia will maintained with desflurane 6-7vol%.

Intervention Type DRUG

Other Intervention Names

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sevofrane suprane

Eligibility Criteria

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Inclusion Criteria

* American society of anesthesiologist class 1 patients
* 3-6 years children undergoing entropion surgery

Exclusion Criteria

* Do not agree with participate this study
Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inje University

OTHER

Sponsor Role lead

Responsible Party

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Ki Hwa Lee

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ki Hwa Lee, M.D,

Role: PRINCIPAL_INVESTIGATOR

Inje University

Locations

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Haeundae paik hospital, inje university

Busan, , South Korea

Site Status

Countries

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South Korea

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2016-01

Identifier Type: -

Identifier Source: org_study_id

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