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Comparison of Two Regimens of Anesthesia for Children Undergoing Magnetic Resonance Imaging (MRI) in General Anesthesia

Sponsor
Niels Anker Pedersen (Other)
Overall Status
Completed
CT.gov ID
NCT00949507
Collaborator
(none)
120
Enrollment
1
Location
30.9
Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Comparison of two regimens (Sevorane/LMA ctr. Propofol/Remifentanil) for children undergoing MRI in general anesthesia.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    120 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Comparison of Two Regimens of Anesthesia for Children Undergoing MRI in General Anesthesia. Advantages, Disadvantages and Time Consumption Regarding the Two Regimens.
    Study Start Date :
    Oct 1, 2008
    Actual Primary Completion Date :
    May 1, 2011
    Actual Study Completion Date :
    May 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    anaesthesia using propofol

    the children are anaesthetized using intravenous anaesthesia with propofol and remifentanil; a binasal catheter is used for administration of oxygen during the anaesthesia
    anaesthesia using sevoflurane

    the patients are anaesthetized using sevoflurane 1 MAC; a laryngeal mask is used

    Outcome Measures

    Primary Outcome Measures

    1. postanaesthetic recovery and behavioral score [0-24 hours hours postoperatively]

    Secondary Outcome Measures

    1. Time span of the recovery process [0-3 hours postoperatively]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 10 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • children aged 1 to 10 yrs.

    • ASA 1-2

    Exclusion Criteria:

    • Allergy to soya (propofol)

    • Allergy to Pentobarbital

    • Allergy to Remifentanil

    • Allergy to Sevoflurane

    • Children undergoing blood tests or further examinations in conjunction with the MRI

    • Children with unexplained fever

    • Children which are evaluated not to be able to keep a open airway

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Glostrup University Hospital, Dept. of Anesthesia Glostrup Copenhagen Denmark DK-2600

    Sponsors and Collaborators

    • Niels Anker Pedersen

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Niels Anker Pedersen, MD, Glostrup University Hospital, Copenhagen
    ClinicalTrials.gov Identifier:
    NCT00949507
    Other Study ID Numbers:
    • 2008-209
    • EudraCT 2008-002690-12
    • 2008-41-2609
    • 2612-3762
    • H-A-2008-060
    First Posted:
    Jul 30, 2009
    Last Update Posted:
    May 27, 2013
    Last Verified:
    May 1, 2013

    Study Results

    No Results Posted as of May 27, 2013