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Post Extubation Delirium and End-tidal Sevoflurane Concentration

Primary Purpose

Delirium on Emergence

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
sevoflurane
Sevoflurane
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium on Emergence focused on measuring sevoflurane, emergence delirium, preschool

Eligibility Criteria

2 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 2-7 years
  • ASA I - II
  • Estimated surgery time < 2 hours
  • Sevoflurane induction and maintenance along with caudal block or Axillary Block

Exclusion Criteria:

  • Craniofacial anomalies
  • Difficult exposure of the vocal cordS
  • Obesity
  • Asthma
  • Invalid caudal block or axillary block

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    low concentration (LC)

    high concentration (HC)

    Arm Description

    low concentration group

    high concentration group

    Outcomes

    Primary Outcome Measures

    Number of Participants With Emergence Delirium (ED)
    The primary outcome was the number of participants with emergence delirium (ED) according to the peak PAED score measured by Pediatric Anesthesia Emergence Delirium Scale. All PAED (Pediatric Anesthesia Emergence Delirium scale) scores were assessed by a dedicated nurse who was blinded to the random assignment of patients to group. PAED scores were assessed on awakening (defined as reactive to verbal command or opening of eyes or crying in response to slight touch) and then every 5 minutes for 30 minutes. If the PAED score was ≥ 16, propofol 1 mg.kg-1 was administrated. After administration of propofol, PAED scores were no longer assessed. The peak (highest) PAED score for each patient was analyzed. ED was defined as a peak PAED score >12. Higher score of PAED means a worse outcome.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 16, 2015
    Last Updated
    July 27, 2021
    Sponsor
    Children's Hospital of Fudan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02489734
    Brief Title
    Post Extubation Delirium and End-tidal Sevoflurane Concentration
    Official Title
    Association Between Post Extubation Delirium and Pre-extubation End-tidal Sevoflurane Concentration in Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2015 (undefined)
    Primary Completion Date
    September 2015 (Actual)
    Study Completion Date
    September 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Children's Hospital of Fudan University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether the incidence of emergence delirium will be reduced when end-tidal concentration of sevoflurane decreases.
    Detailed Description
    Sevoflurane induction and maintenance were selected. Intubation was performed after lidocaine spray on vocal cord. After that, an effective caudal or brachial plexus block was performed. End-tidal concentration of sevoflurane was maintained at 2.5%. Spontaneous respiratory was maintained. Sevoflurane was stopped after the end of surgery. Patients were randomly assigned to 2 groups: high concentration group (Group HC, end-tidal concentration of sevoflurane when extubating >=0.5%) and low concentration group (Group LC, end-tidal concentration of sevoflurane when extubating <0.5%). Patients in Group LC were extubated when they coughed or purposeful movement appeared. The patients whose end-tidal concentration of sevoflurane >= 0.5% were excluded. Patients in Group HC were extubated when any of the criteria was met: 1.the patient coughed or purposeful movement appeared 2.end-tidal concentration of sevoflurane decreased to 0.5%. A trained nurse (blind to groups) recorded PAEDs scores in PACU.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Delirium on Emergence
    Keywords
    sevoflurane, emergence delirium, preschool

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    109 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    low concentration (LC)
    Arm Type
    Experimental
    Arm Description
    low concentration group
    Arm Title
    high concentration (HC)
    Arm Type
    Experimental
    Arm Description
    high concentration group
    Intervention Type
    Drug
    Intervention Name(s)
    sevoflurane
    Intervention Description
    extubation when end-tidal concentration of sevoflurane < 0.5%
    Intervention Type
    Drug
    Intervention Name(s)
    Sevoflurane
    Intervention Description
    extubation when end-tidal concentration of sevoflurane >= 0.5%
    Primary Outcome Measure Information:
    Title
    Number of Participants With Emergence Delirium (ED)
    Description
    The primary outcome was the number of participants with emergence delirium (ED) according to the peak PAED score measured by Pediatric Anesthesia Emergence Delirium Scale. All PAED (Pediatric Anesthesia Emergence Delirium scale) scores were assessed by a dedicated nurse who was blinded to the random assignment of patients to group. PAED scores were assessed on awakening (defined as reactive to verbal command or opening of eyes or crying in response to slight touch) and then every 5 minutes for 30 minutes. If the PAED score was ≥ 16, propofol 1 mg.kg-1 was administrated. After administration of propofol, PAED scores were no longer assessed. The peak (highest) PAED score for each patient was analyzed. ED was defined as a peak PAED score >12. Higher score of PAED means a worse outcome.
    Time Frame
    within 30 minutes after awakening

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    7 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 2-7 years ASA I - II Estimated surgery time < 2 hours Sevoflurane induction and maintenance along with caudal block or Axillary Block Exclusion Criteria: Craniofacial anomalies Difficult exposure of the vocal cordS Obesity Asthma Invalid caudal block or axillary block
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xuan Wang
    Organizational Affiliation
    Children's Hospital of Fudan University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Post Extubation Delirium and End-tidal Sevoflurane Concentration

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