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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Niels Anker Pedersen, Glostrup University Hospital,Copenhagen
ClinicalTrials.gov Identifier:
NCT00949507
First received: July 29, 2009
Last updated: May 24, 2013
Last verified: May 2013
History of Changes
  Purpose

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


Condition Phase
General Anesthesia
Children
MRI
Sevoflurane
Propofol/Remifentanil
 Phase 4

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:

MedlinePlus related topics: MRI Scans
U.S. FDA Resources

Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • postanaesthetic recovery and behavioral score [ Time Frame: 0-24 hours hours postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time span of the recovery process [ Time Frame: 0-3 hours postoperatively ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: October 2008
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   1 Year to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00949507

Locations
Denmark
Glostrup University Hospital, Dept. of Anesthesia
Glostrup, Copenhagen, Denmark, DK-2600
Sponsors and Collaborators
Niels Anker Pedersen
  More Information

No publications provided

Responsible Party: Niels Anker Pedersen, MD, Glostrup University Hospital,Copenhagen
ClinicalTrials.gov Identifier: NCT00949507     History of Changes
Other Study ID Numbers: 2008-209, EudraCT 2008-002690-12, 2008-41-2609, 2612-3762, H-A-2008-060
Study First Received: July 29, 2009
Last Updated: May 24, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013