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NCT00949507 Clinical Trial

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

Children Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00949507
Other study ID # 2008-209
Secondary ID EudraCT 2008-002
Status Completed
Phase Phase 4
First received July 29, 2009
Last updated May 24, 2013
Start date October 2008
Est. completion date May 2011

Study information
Verified date May 2013
Source Glostrup University Hospital, Copenhagen
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: The Regional Committee on Biomedical Research Ethics
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date May 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 10 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Glostrup University Hospital, Dept. of Anesthesia Glostrup Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Niels Anker Pedersen

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary postanaesthetic recovery and behavioral score 0-24 hours hours postoperatively No
Secondary Time span of the recovery process 0-3 hours postoperatively No
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