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

May 24, 2013 updated by: Niels Anker Pedersen

Comparison of Two Regimens of Anesthesia for Children Undergoing MRI in General Anesthesia. Advantages, Disadvantages and Time Consumption Regarding the Two Regimens.

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen
      • Glostrup, Copenhagen, Denmark, DK-2600
        • Glostrup University Hospital, Dept. of Anesthesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

120 children ASA 1-2 aged 1 to 10 yrs. scheduled for MRI in general anesthesia

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postanaesthetic recovery and behavioral score
Time Frame: 0-24 hours hours postoperatively
0-24 hours hours postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Time span of the recovery process
Time Frame: 0-3 hours postoperatively
0-3 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Niels Anker Pedersen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

July 29, 2009

First Submitted That Met QC Criteria

July 29, 2009

First Posted (Estimate)

July 30, 2009

Study Record Updates

Last Update Posted (Estimate)

May 27, 2013

Last Update Submitted That Met QC Criteria

May 24, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 2008-209
  • EudraCT 2008-002690-12
  • 2008-41-2609
  • 2612-3762
  • H-A-2008-060

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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