search
Back to results

The Occurrence of Emergence Agitation in Pediatric Strabismus Surgery

Primary Purpose

Emergence Delirium, Strabismus, Pediatric ALL

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Bridion 200 MG in 2 ML Injection
Neostigmine Methylsulfate
Sponsored by
Konkuk University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Emergence Delirium

Eligibility Criteria

4 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Pateints scheduled elective stramismus surgery aged 4-7 with American Society of Anesthesiologists (ASA) classification 1-3. Exclusion Criteria: ASA classification 3 or more impaired liver function impaired kidney function myasthenia gravis or other neuromuscular disorders history of drug allergy cardiovascular disease or arryrhthmia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    group neostigmine

    group sugammadex

    Arm Description

    If TOF count is 1 or less, wait until it becomes 2 and then give the patient neostigmine dose of 50mcg/kg. If TOF count shows 4 with fade, 40mcg/kg of neostigmine is administered and without fade, 20mcg/kg is administered.

    If TOF count shows 0 and PTC (posttetanic count) is 1 or more, sugamadex administered dose of 4mg/kg. If TOF count shows 1 or more, 2mg/kg is administered.

    Outcomes

    Primary Outcome Measures

    The incidence of EA in postanesthesia care unit (PACU)
    EA is assessed with the PAED scale in PACU. EA is defined as the score is 10 or higher.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 6, 2023
    Last Updated
    September 6, 2023
    Sponsor
    Konkuk University Medical Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT06035757
    Brief Title
    The Occurrence of Emergence Agitation in Pediatric Strabismus Surgery
    Official Title
    The Effect of Administration of Sugammadex on the Occurrence of Emergence Agitation in Pediatric Strabismus Surgery-prospective Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 15, 2023 (Anticipated)
    Primary Completion Date
    August 15, 2024 (Anticipated)
    Study Completion Date
    August 15, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Konkuk University Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The present tiral conduted to demonstrate the administration of sugammadex as reversal of neuromuscular blockade agent reduces the incedence of emergence agitation (EA) comparing to neostigmine
    Detailed Description
    EA is one of the most common postoperative complications in after general anesthesia in pre-school aged pediatric patients. There are several causes contributed to occurrence of EA such as postoperative pain, type of surgery and surgical site, hyperthermia or hypothermia. Some researches showed that the occurrence of EA is associated with patients' anxiety and we inferred that patients' anxiety after general anesthesia could be related to ability to breathe. Ability to breathe is highly associated with level of residual neuromuscular blockade (NMB) after recovery from general anesthesia. We evaluate the Pediatric Anesthesia Emergence Delirium (PAED) Scale to investigate whether sugammadex as reversal agents of NMB reduces the incidence of EA in pediatric patients who undergo strabismus surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Emergence Delirium, Strabismus, Pediatric ALL

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    76 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    group neostigmine
    Arm Type
    Active Comparator
    Arm Description
    If TOF count is 1 or less, wait until it becomes 2 and then give the patient neostigmine dose of 50mcg/kg. If TOF count shows 4 with fade, 40mcg/kg of neostigmine is administered and without fade, 20mcg/kg is administered.
    Arm Title
    group sugammadex
    Arm Type
    Active Comparator
    Arm Description
    If TOF count shows 0 and PTC (posttetanic count) is 1 or more, sugamadex administered dose of 4mg/kg. If TOF count shows 1 or more, 2mg/kg is administered.
    Intervention Type
    Drug
    Intervention Name(s)
    Bridion 200 MG in 2 ML Injection
    Other Intervention Name(s)
    Bridion
    Intervention Description
    Sugammadex and neostigmine are administered at the end of surgery after assessment of the level of neuromuscular blockade is done. The dosage of each revesal agent is determined with response to TOF or PTC.
    Intervention Type
    Drug
    Intervention Name(s)
    Neostigmine Methylsulfate
    Other Intervention Name(s)
    neostigmine
    Intervention Description
    Sugammadex and neostigmine are administered at the end of surgery after assessment of the level of neuromuscular blockade is done. The dosage of each revesal agent is determined with response to TOF or PTC.
    Primary Outcome Measure Information:
    Title
    The incidence of EA in postanesthesia care unit (PACU)
    Description
    EA is assessed with the PAED scale in PACU. EA is defined as the score is 10 or higher.
    Time Frame
    EA is assessed three times at 15-min intervals from the end of anesthesia to dischrage from PACU.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    7 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Pateints scheduled elective stramismus surgery aged 4-7 with American Society of Anesthesiologists (ASA) classification 1-3. Exclusion Criteria: ASA classification 3 or more impaired liver function impaired kidney function myasthenia gravis or other neuromuscular disorders history of drug allergy cardiovascular disease or arryrhthmia
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yea-Ji Lee, M.D Ph. D
    Phone
    +82-2-2030-5450
    Email
    ladydaisy82@naver.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yea-Ji Lee, M.D Ph. D
    Organizational Affiliation
    Konkuk University Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Occurrence of Emergence Agitation in Pediatric Strabismus Surgery

    We'll reach out to this number within 24 hrs