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Study comparing effects of propofol and sevoflurane on kidney blood flow using magnetic resonance imaging in children at risk of post-operative kidney injury

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Post-operative Acute Kidney Injury in children and examines how two different types of anesthesia medications affect blood flow to the kidneys. The medications being studied are propofol, given through a vein, and sevoflurane, which is inhaled. These are common anesthetic medications used to help patients sleep during medical procedures.

The purpose of this research is to understand how these two different anesthesia medications affect kidney blood flow in children who need to undergo Magnetic Resonance Imaging (MRI). During the study, children will receive either propofol or sevoflurane while having their MRI scan. Special imaging techniques will be used to look at how blood flows through the kidneys during anesthesia.

The study involves children between 1 month and 14 years of age who already need to have an MRI scan with anesthesia as part of their regular medical care. During the procedure, researchers will measure kidney blood flow and oxygen levels using special MRI techniques. They will also take a blood sample to measure certain kidney-related substances in the blood.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial anesthesia preparation
You will be randomly assigned to receive one of two types of anesthesia: either propofol (given through a vein) or sevoflurane (given through breathing).
A doctor will evaluate your physical condition according to ASA (American Society of Anesthesiologists) standards before the procedure.
Step 2
MRI scanning procedure
You will undergo a special type of magnetic resonance imaging (MRI) scan that looks at blood flow in your kidneys.
During the scan, the medical team will monitor your blood pressure and other vital signs.
The scan will measure how blood flows through your kidneys using different MRI techniques.
Step 3
Blood sample collection
A blood sample will be taken to measure the level of renin (a hormone that helps control blood pressure) in your blood.
Step 4
Additional kidney measurements
The MRI will measure oxygen levels in different parts of your kidneys using a technique called BOLD (Blood Oxygen Level Dependent) imaging.
Another type of measurement called arterial spin labelling (ASL) will show how well blood is flowing to different parts of your kidneys.
Step 5
Monitoring period
After the procedure, medical staff will monitor your recovery from anesthesia.
Your kidney function will be checked to ensure there are no complications.

Who can join the trial?

6 criteria

Patient must be a child between 1 month and 14 years of age
Patient must be scheduled for an MRI scan (Magnetic Resonance Imaging - a medical imaging technique that uses magnetic fields and radio waves to create detailed images of organs and tissues) that requires anesthesia
Patient must have a physical health status that falls within ASA categories I to III (ASA is a system used by doctors to assess a patient's physical health before surgery, where:
- ASA I means a normal healthy person
- ASA II means a patient with mild systemic disease
- ASA III means a patient with severe systemic disease
- Both male and female patients can participate

Who cannot join the trial?

12 criteria

Children younger than 2 years old
Known allergy or hypersensitivity to Propofol (an anesthetic medication used for sedation)
Known allergy or hypersensitivity to Sevoflurane (an inhaled anesthetic gas)
Pre-existing kidney disease or impaired kidney function
Current use of medications that affect kidney function
Significant heart conditions that could affect blood flow
History of adverse reactions to anesthesia
Active infections or fever
Participation in other clinical trials within the past 30 days
Any condition that could interfere with renal blood flow (blood flow to the kidneys) measurements
Inability to obtain informed consent from parents or legal guardians
Any medical condition that the study doctor determines would make participation unsafe

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Verified sites

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Uppsala University Hospital
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Uppsala, Sweden

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Investigated drugs

Propofol is an intravenous anesthetic medication used to induce and maintain general anesthesia during medical procedures. It works by slowing down the activity of the brain and nervous system, helping patients fall asleep quickly for surgery. This medication is commonly used in both adults and children. Sevoflurane is an inhaled anesthetic gas that is breathed in through a mask to produce and maintain general anesthesia. It has a pleasant smell and allows patients to fall asleep gently, making it particularly suitable for use in children. Patients breathe the medication through a special breathing system during surgery. Magnetic Resonance Imaging (MRI) is used in this study to observe and measure blood flow to the kidneys while patients are under anesthesia. While not a medication, this imaging technique helps doctors understand how these anesthetic medications affect blood flow in the body.

What is already known about the treatment

Propofol
An intravenous anesthetic medication administered through injection that quickly induces and maintains general anesthesia. This widely-used drug works by enhancing the effects of GABA neurotransmitters in the brain, leading to sedation and unconsciousness. Propofol is commonly used in both hospital and outpatient settings for surgical procedures, with its main advantage being rapid onset and quick recovery time, though it requires careful monitoring of vital signs during administration.
Sevoflurane
A volatile anesthetic agent administered through inhalation that is commonly used for induction and maintenance of general anesthesia, especially in pediatric patients. This medication works by altering nerve transmission in the brain through interaction with various neurotransmitter receptors, producing unconsciousness and preventing pain sensation. Sevoflurane is particularly valued in pediatric anesthesia due to its pleasant smell, low blood solubility allowing for quick onset and recovery, and minimal respiratory irritation.

Investigated diseases

Post-operative Acute Kidney Injury - A sudden decline in kidney function that occurs within hours to days after surgery. The condition develops when the kidneys suddenly stop filtering waste products from the blood properly. It causes a rapid buildup of waste products in the blood, along with fluid and electrolyte imbalances. The condition can affect urine output, which may decrease significantly or stop completely. The kidneys may become temporarily unable to maintain the proper balance of fluids and minerals in the body. This condition is typically reversible if identified and addressed early.