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Dose Titration of Propofol for Tracheal Intubation in Children With Sevoflurane Inhalation Induction

Primary Purpose

Pediatric Urinary Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
propofol
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pediatric Urinary Disorders

Eligibility Criteria

6 Months - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pediatric patients scheduled for elective day case surgery were enrolled.

Exclusion Criteria:

  • History of obstructive sleep apnea
  • Evidence of cardiorespiratory disease
  • Those who were obese or allergic to any of the anesthetic agents in this study
  • Those with an anticipated difficult airway, full stomach
  • History of malignant hyperthermia or other myopathy were excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    propofol

    Arm Description

    Outcomes

    Primary Outcome Measures

    Assessment of intubation conditions
    Assessment of intubation conditions (vocal cord, intubation condition, cough, movement) , peri-induction HR and BP change, post-operative agitation socre at recovery room. ED50 and ED 95 of each group by uring Dixon's up and down methods. peri -induction period -comparison of above factors among each groups (GroupA: ETSevo 3vol%, Group B: ETSevo 3.5vol%, Group: ET Sevo 4vol%)

    Secondary Outcome Measures

    Full Information

    First Posted
    March 5, 2010
    Last Updated
    February 17, 2014
    Sponsor
    Yonsei University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01084031
    Brief Title
    Dose Titration of Propofol for Tracheal Intubation in Children With Sevoflurane Inhalation Induction
    Official Title
    Dose Titration of Propofol for Tracheal Intubation in Children With Sevoflurane Inhalation Induction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2009 (undefined)
    Primary Completion Date
    February 2010 (Actual)
    Study Completion Date
    March 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Yonsei University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Dose titration of propofol for tracheal intubation in children with sevoflurane inhalation induction.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pediatric Urinary Disorders

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    propofol
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    propofol
    Intervention Description
    intravenous propofol with sevoflurane inhalation induction
    Primary Outcome Measure Information:
    Title
    Assessment of intubation conditions
    Description
    Assessment of intubation conditions (vocal cord, intubation condition, cough, movement) , peri-induction HR and BP change, post-operative agitation socre at recovery room. ED50 and ED 95 of each group by uring Dixon's up and down methods. peri -induction period -comparison of above factors among each groups (GroupA: ETSevo 3vol%, Group B: ETSevo 3.5vol%, Group: ET Sevo 4vol%)
    Time Frame
    30 minutes after the surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    5 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Pediatric patients scheduled for elective day case surgery were enrolled. Exclusion Criteria: History of obstructive sleep apnea Evidence of cardiorespiratory disease Those who were obese or allergic to any of the anesthetic agents in this study Those with an anticipated difficult airway, full stomach History of malignant hyperthermia or other myopathy were excluded.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hae Keum Kil
    Organizational Affiliation
    Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Dose Titration of Propofol for Tracheal Intubation in Children With Sevoflurane Inhalation Induction

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