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Consequence of Dexmedetomidine on Emergence Deliruim After Sevoflurane Anesthesia in Children With Cerebral Palsy

Primary Purpose

Emergence Deliruim; Cerebral Palsy

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
dexmedetomidine
Sponsored by
Jin Ni
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Emergence Deliruim; Cerebral Palsy focused on measuring children

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Non-quadriplegic (mono-,di-, hemiplegic) children with CP that are scheduled for elective Achilles-tendon lengthening procedure Guangzhou Women and Children's Medical Center, Guangzhou, China, with American Society of Anesthesiologists (ASA) physical status I or II.

Exclusion Criteria:

Participants that displayed symptoms of sinus bradycardia and atrio-ventricular block, non-communicative severe developmental delay, seizure disorders, and treatment with seizure medications

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Group C

    Group D

    Arm Description

    Five minutes prior to the commencement of the surgical procedure, Group D participants were administered 10 ml NaCI 0.9%.

    Five minutes prior to the commencement of the surgical procedure, Group D participants were administered dexmedetomidine 0.5μg•kg-1 diluted in 10 ml NaCI 0.9%

    Outcomes

    Primary Outcome Measures

    pediatric anesthesia emergence delirium (PAED) scale
    Heart rate
    systolic blood pressure
    diastolic blood pressure

    Secondary Outcome Measures

    Full Information

    First Posted
    September 17, 2014
    Last Updated
    September 18, 2014
    Sponsor
    Jin Ni
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02244515
    Brief Title
    Consequence of Dexmedetomidine on Emergence Deliruim After Sevoflurane Anesthesia in Children With Cerebral Palsy
    Official Title
    Consequence of Dexmedetomidine on Emergence Deliruim After Sevoflurane Anesthesia in Children With Cerebral Palsy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2014 (undefined)
    Primary Completion Date
    September 2014 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Jin Ni

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether dexmedetomidine is effective in the treatment of emergence deliruim after sevoflurane anesthesia in children with cerebral palsy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Emergence Deliruim; Cerebral Palsy
    Keywords
    children

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Group C
    Arm Type
    Placebo Comparator
    Arm Description
    Five minutes prior to the commencement of the surgical procedure, Group D participants were administered 10 ml NaCI 0.9%.
    Arm Title
    Group D
    Arm Type
    Experimental
    Arm Description
    Five minutes prior to the commencement of the surgical procedure, Group D participants were administered dexmedetomidine 0.5μg•kg-1 diluted in 10 ml NaCI 0.9%
    Intervention Type
    Drug
    Intervention Name(s)
    dexmedetomidine
    Intervention Description
    dexmedetomidine 0.5μg•kg-1 diluted in 10 ml NaCI 0.9%
    Primary Outcome Measure Information:
    Title
    pediatric anesthesia emergence delirium (PAED) scale
    Time Frame
    during stay in postanesthesia care unit
    Title
    Heart rate
    Time Frame
    during surgical procedures
    Title
    systolic blood pressure
    Time Frame
    during surgical procedures
    Title
    diastolic blood pressure
    Time Frame
    during surgical procedures

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Non-quadriplegic (mono-,di-, hemiplegic) children with CP that are scheduled for elective Achilles-tendon lengthening procedure Guangzhou Women and Children's Medical Center, Guangzhou, China, with American Society of Anesthesiologists (ASA) physical status I or II. Exclusion Criteria: Participants that displayed symptoms of sinus bradycardia and atrio-ventricular block, non-communicative severe developmental delay, seizure disorders, and treatment with seizure medications

    12. IPD Sharing Statement

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    Consequence of Dexmedetomidine on Emergence Deliruim After Sevoflurane Anesthesia in Children With Cerebral Palsy

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