Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613000944730
Ethics application status
Approved
Date submitted
5/08/2013
Date registered
27/08/2013
Date last updated
8/08/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Different protocols for children in Magnetic Resonance Imaging (MRI) : general anesthesia, sedation or none?
Scientific title
Different protocols for children in Magnetic Resonance (MRI) imaging: general anesthesia, sedation or none? A retrospective analysis of patient records
Secondary ID [1] 282974 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
We will search techniques used in children undergoing brain, thorax, abdomen or vertebral MRI 289800 0
Condition category
Condition code
Anaesthesiology 290153 290153 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure

We will retrospectively search the patient files to determine the technique used in children undergoing MRI such as general anesthesia, sedation or behavioral approaches in our hospital from February 2012-August 2012.
Intervention code [1] 287689 0
Other interventions
Comparator / control treatment
We will evaluate the anesthesia records retrospectively. There is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290180 0
We will retrospectively analyse the children's medical records who attended to practice MRI to detect if they had general anesthesia, sedation or behavioral approaches in our hospital from February 2012 to August 2012.
Timepoint [1] 290180 0
From August 12/2013 to august 22/2013, we want to retrospectively analyse the records of children who attended MRI between February to August 2012.
Secondary outcome [1] 304067 0
none
Timepoint [1] 304067 0
none

Eligibility
Key inclusion criteria
Children 0-16 years age receiving MRI from February 2012-August 2012.
Minimum age
0 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients older than 16 years,
MRI before February 2012- after August 2012.
patients having fever or full stomach

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/09/2013
Actual
Date of last participant enrolment
Anticipated
16/09/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 5268 0
Turkey
State/province [1] 5268 0
Ankara

Funding & Sponsors
Funding source category [1] 287745 0
Self funded/Unfunded
Name [1] 287745 0
gozde Bumin Aydin
Country [1] 287745 0
Turkey
Primary sponsor type
Individual
Name
Gozde Bumin Aydin
Address
Gozde Bumin Aydin
Orun villalari 2764. sok no 7 Cayyolu Ankara 06610
Diskapi Yildirim Beyazit Education and Reasearch Hospital
Country
Turkey
Secondary sponsor category [1] 286470 0
None
Name [1] 286470 0
none
Address [1] 286470 0
none
Country [1] 286470 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Giving anesthesia outside the operation room, expecially in MRI is a serious anxiety for anesthesiologists. Most of the adults and children are afraid of recieving MRI also children has %20 of unexpected complications in recieving general anesthesia in MRI.
We want to retrospectively evaluate the records of children(0-16 years old) if they had general anesthesia, sedation or behavioral therapy in February to August 2012 while practising MRI in our hospital.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42018 0
Dr Gozde Bumin Aydin
Address 42018 0
Gozde Bumin Aydin
Orun villalari 2764. sok no 7 Cayyolu Ankara 06610
Diskapi Yildirim Beyazit Education and Reasearch Hospital
Country 42018 0
Turkey
Phone 42018 0
+905326453235
Fax 42018 0
Email 42018 0
[email protected]
Contact person for public queries
Name 42019 0
Dr Gozde Bumin Aydin
Address 42019 0
Gozde Bumin Aydin
Orun villalari 2764. sok no 7 Cayyolu Ankara 06610
Diskapi Yildirim Beyazit Education and Reasearch Hospital
Country 42019 0
Turkey
Phone 42019 0
+905326453235
Fax 42019 0
Email 42019 0
[email protected]
Contact person for scientific queries
Name 42020 0
Dr Gozde Bumin Aydin
Address 42020 0
Gozde Bumin Aydin
Orun villalari 2764. sok no 7 Cayyolu Ankara 06610
Diskapi Yildirim Beyazit Education and Reasearch Hospital
Country 42020 0
Turkey
Phone 42020 0
+905326453235
Fax 42020 0
Email 42020 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.