We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02916407
Recruitment Status : Completed
First Posted : September 27, 2016
Results First Posted : May 3, 2019
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Ki Hwa Lee, Inje University

Tracking Information
First Submitted Date  ICMJE September 1, 2016
First Posted Date  ICMJE September 27, 2016
Results First Submitted Date  ICMJE December 14, 2018
Results First Posted Date  ICMJE May 3, 2019
Last Update Posted Date May 3, 2019
Study Start Date  ICMJE September 2016
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2019)
Extubation Time [ Time Frame: 30 minutes ]
compare the extubation time between sevoflurane and desflurane group
Original Primary Outcome Measures  ICMJE
 (submitted: September 24, 2016)
extubation time [ Time Frame: 30 minutes ]
compare the extubation time between sevoflurane and desflurane group
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2019)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2016)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Preoperative Ketamine on the Emergence Characteristics in Children Undergoing Entropion Surgery
Official Title  ICMJE The Effect of Preoperative Ketamine on the Emergence Characteristics After Desflurane or Sevoflurane Anesthesia in Children Undergoing Entropion Surgery
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Entropion
Intervention  ICMJE
  • Drug: 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 Name: sevofrane
  • Drug: Desflurane

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

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

    Other Name: suprane
Study Arms  ICMJE
  • Active Comparator: Sevoflurane Group
    The patients will maintained general anesthesia with sevoflurane.
    Intervention: Drug: Sevoflurane
  • Experimental: Desflurane Group
    The patients will maintained general anesthesia with desflurane.
    Intervention: Drug: Desflurane
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 24, 2016)
56
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2017
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02916407
Other Study ID Numbers  ICMJE 2016-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Ki Hwa Lee, Inje University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Inje University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ki Hwa Lee, M.D, Inje University
PRS Account Inje University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP