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: July 3, 2012

Last verified: July 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	July 29, 2009
Last Updated Date	July 3, 2012
Start Date ^ICMJE	October 2008
Primary Completion Date	May 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 29, 2009)	postanaesthetic recovery and behavioral score [ Time Frame: 0-24 hours hours postoperatively ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00949507 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 29, 2009)	Time span of the recovery process [ Time Frame: 0-3 hours postoperatively ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Comparison of Two Regimens of Anesthesia for Children Undergoing Magnetic Resonance Imaging (MRI) in General Anesthesia
Official Title ^ICMJE	Comparison of Two Regimens of Anesthesia for Children Undergoing MRI in General Anesthesia. Advantages, Disadvantages and Time Consumption Regarding the Two Regimens.
Brief Summary	Comparison of two regimens (Sevorane/LMA ctr. Propofol/Remifentanil) for children undergoing MRI in general anesthesia.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	120 children ASA 1-2 aged 1 to 10 yrs. scheduled for MRI in general anesthesia
Condition ^ICMJE	General Anesthesia Children MRI Sevoflurane Propofol/Remifentanil
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	120
Completion Date	May 2011
Primary Completion Date	May 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	1 Year to 10 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Denmark

Administrative Information
NCT Number ^ICMJE	NCT00949507
Other Study ID Numbers ^ICMJE	2008-209, EudraCT 2008-002690-12, 2008-41-2609, 2612-3762, H-A-2008-060
Has Data Monitoring Committee	Yes
Responsible Party	Niels Anker Pedersen, Glostrup University Hospital,Copenhagen
Study Sponsor ^ICMJE	Niels Anker Pedersen
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Glostrup University Hospital, Copenhagen
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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