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

April 29, 2019 updated by: Ki Hwa Lee, Inje University

The Effect of Preoperative Ketamine on the Emergence Characteristics After Desflurane or Sevoflurane Anesthesia in Children Undergoing Entropion Surgery

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

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Busan, Korea, Republic of, 612-896
        • Haeundae paik hospital, inje university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 6 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Sevoflurane Group
The patients will maintained general anesthesia with sevoflurane.

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

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

Other Names:
  • sevofrane
EXPERIMENTAL: Desflurane Group
The patients will maintained general anesthesia with desflurane.

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

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

Other Names:
  • suprane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extubation Time
Time Frame: 30 minutes
compare the extubation time between sevoflurane and desflurane group
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of Postoperative Agitation
Time Frame: 30 minutes

Postoperative agitation will measure using Pediatric Anesthesia Emergence Delirium (PAED) scale. PAED scale is "(1) The child makes eye contact with the caregiver (2) The child's action are purposeful (3) The child is aware of his/her surrounding (4) The child is restless (5) The child is inconsolable." It scores 0-4, and total maximum score is 20.

PAED score > 12 was used to determine occurence of postoperative agitation.

30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Ki Hwa Lee, M.D,, Inje University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (ACTUAL)

November 1, 2017

Study Completion (ACTUAL)

November 1, 2017

Study Registration Dates

First Submitted

September 1, 2016

First Submitted That Met QC Criteria

September 24, 2016

First Posted (ESTIMATE)

September 27, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 3, 2019

Last Update Submitted That Met QC Criteria

April 29, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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