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

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ClinicalTrials.gov Identifier: NCT00949507
Recruitment Status : Completed
First Posted : July 30, 2009
Last Update Posted : May 27, 2013
Sponsor:
Information provided by (Responsible Party):
Niels Anker Pedersen, Glostrup University Hospital, Copenhagen

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

Condition or disease
General Anesthesia Children MRI Sevoflurane Propofol/Remifentanil

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 : October 2008
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia

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



Primary Outcome Measures :
  1. postanaesthetic recovery and behavioral score [ Time Frame: 0-24 hours hours postoperatively ]

Secondary Outcome Measures :
  1. Time span of the recovery process [ Time Frame: 0-3 hours postoperatively ]


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Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00949507


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

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
First Posted: July 30, 2009    Key Record Dates
Last Update Posted: May 27, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs