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

Ketamine

Brief Summary

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

Intervention / Treatment

  • Sevoflurane (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 (DRUG)
    Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children. General anesthesia will maintained with desflurane 6-7vol%.

Condition or Disease

  • Entropion

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 3 Years to 6 Years
    Enrollment: 56 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Other

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Sep 01, 2016
    Primary Completion: Nov 01, 2017 ACTUAL
    Completion Date: Nov 01, 2017 ACTUAL
    Study First Posted: Sep 27, 2016 ESTIMATED
    Results First Posted: May 03, 2019 ACTUAL
    Last Updated: Apr 29, 2019

    Sponsors / Collaborators

    Lead Sponsor: Inje University
    Responsible Party: N/A

    Location

    South Korea
    Busan, South Korea

    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.

    Participant Groups

    • The patients will maintained general anesthesia with sevoflurane.

    • The patients will maintained general anesthesia with desflurane.

    Eligibility Criteria

    Sex: All
    Minimum Age: 3
    Maximum Age: 6
    Age Groups: Child
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • compare the extubation time between sevoflurane and desflurane group

    Secondary Outcomes

    • 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.

    More Details

    NCT Number: NCT02916407
    Other IDs: 2016-01
    Study URL: https://clinicaltrials.gov/study/NCT02916407
    Last updated: Sep 29, 2023