search
Back to results

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

Primary Purpose

Entropion

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sevoflurane
Desflurane
Sponsored by
Inje University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Entropion focused on measuring Anesthesia, Agitation, Extubation

Eligibility Criteria

3 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Haeundae paik hospital, inje university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Sevoflurane Group

Desflurane Group

Arm Description

The patients will maintained general anesthesia with sevoflurane.

The patients will maintained general anesthesia with desflurane.

Outcomes

Primary Outcome Measures

Extubation Time
compare the extubation time between sevoflurane and desflurane group

Secondary Outcome Measures

Degree of Postoperative Agitation
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.

Full Information

First Posted
September 1, 2016
Last Updated
April 29, 2019
Sponsor
Inje University
search

1. Study Identification

Unique Protocol Identification Number
NCT02916407
Brief Title
The Effect of Preoperative Ketamine on the Emergence Characteristics in Children Undergoing Entropion Surgery
Official Title
The Effect of Preoperative Ketamine on the Emergence Characteristics After Desflurane or Sevoflurane Anesthesia in Children Undergoing Entropion Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inje University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Entropion
Keywords
Anesthesia, Agitation, Extubation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sevoflurane Group
Arm Type
Active Comparator
Arm Description
The patients will maintained general anesthesia with sevoflurane.
Arm Title
Desflurane Group
Arm Type
Experimental
Arm Description
The patients will maintained general anesthesia with desflurane.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
sevofrane
Intervention Description
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
Intervention Name(s)
Desflurane
Other Intervention Name(s)
suprane
Intervention Description
Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children. General anesthesia will maintained with desflurane 6-7vol%.
Primary Outcome Measure Information:
Title
Extubation Time
Description
compare the extubation time between sevoflurane and desflurane group
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Degree of Postoperative Agitation
Description
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.
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ki Hwa Lee, M.D,
Organizational Affiliation
Inje University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haeundae paik hospital, inje university
City
Busan
ZIP/Postal Code
612-896
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs