Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06278376 |
| Other study ID # |
f/2023/045 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 25, 2023 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Jessa Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The aim of this study is to evaluate the indications and therapeutical consequences of MRI
scans of (young) children undergoing risky remote anaesthesia. The investigators want to aim
for a clear indication in children undergoing MRI in the future before undergoing possible
unnecessary procedures and MRI scans.
Description:
Magnetic resonance imaging (MRI) is a non-invasive imaging technique that allows physicians
to visualize our anatomy, generating high-quality pictures of our body's internal structure
at many different angles. The principle behind MRI, known as nuclear magnetic resonance
(NMR), revolves around hydrogen atoms (or protons) that can be found everywhere in our entire
body, such as in bones, blood, organs, skin, muscles and more. Protons have their own
magnetic moment and angular momentum, allowing them to spin in a certain direction. By
subjecting these spinning protons to a strong magnetic field they will be oriented along the
axis of the magnetic field, either with or against the direction of the magnetic field. MRI
machines generate this field using a large magnet surrounding the patient. Electric gradient
coils allow the strength of the field to be adjustable, usually around 0,5 or 1,5 tesla.
MRI has many advantages compared to other imaging techniques, i.e. CT (computed tomography),
including the lack of radiation, the ability to show abnormalities of soft tissues, the
ability to visualize blood flow, and contrasting agents that are less likely to cause adverse
effects like allergic reactions. There are also some disadvantages or limitations, however:
implants or metallic objects inside the body can make images unclear at best or harm the
patient at worst; similarly, movements made by the patient can make images unclear as well.
Lastly, MRI is a more expensive and slower technique compared to other imaging techniques.
Children undergoing an MRI are often sedated before being placed inside the machine. After
the scan is over, the children will be brought to a recovery area, where they can slowly
recover from the sedation until they are fully awake again. Some common side effects
resulting from the sedation may be vomiting, drowsiness and/or dizziness.
The aim of this study is to evaluate the indications and therapeutical consequences of MRI
scans of (young) children undergoing risky remote anaesthesia. The investigators want to aim
for a clear indication in children undergoing MRI in the future before undergoing possible
unnecessary procedures and MRI scans.
