PROPOFOL for Post-operative Acute Kidney Injury

Inclusion criteria

• {"criterion_text":"-Pediatric Patients (1 month -14 years of age)\n-Indicated for MRI with anesthesia\n-ASA (American Society of Anesthesiologists) physical status I-III"}

Exclusion criteria

• {"criterion_text":"-Known renal impairment or chronic kidney disease\n-Severe cardiac or pulmonary disease\n-Allergy to either Propofol or Sevoflurane\n-Contraindications to Magnetic Resonance Imaging\n-Contraindications to either Propofol or Sevoflurane\n-Declined participation or declined consent from patients, parents or guardians.\n-Ongoing acute kidney injury\n-Pregnancy. Female participants of childbearing potential (defined as post-menarche) will be excluded if pregnant, confirmed by asking about menstrual and pregnancy status."}

Primary endpoints

• {"endpoint_text":"-Differences in RBF, as measured by phase contrast imaging with mpMRI, between propofol and sevoflurane anesthesia.","definition_or_measurement_approach":"Measured by phase contrast imaging with mpMRI to assess renal blood flow (RBF)."}

Secondary endpoints

• {"endpoint_text":"-The difference plasma renin concentration, measured by a blood sample, between propofol and sevoflurane anaesthesia","definition_or_measurement_approach":"Plasma renin concentration measured from a blood sample."}
• {"endpoint_text":"-The difference in relation of RBF to systemic non-invasive blood pressure, between propofol and sevoflurane anaesthesia","definition_or_measurement_approach":"Assessment of the relation between RBF (measured by mpMRI) and systemic non-invasive blood pressure."}
• {"endpoint_text":"-Differences in regional and global renal oxygenation, as measured by Blood Oxygen Level Dependent (BOLD) signal via mpMRI, between propofol and sevoflurane anaesthesia.","definition_or_measurement_approach":"Renal oxygenation measured by BOLD signal via mpMRI."}
• {"endpoint_text":"-Differences in regional renal tissue perfusion, as measured by arterial spin labelling (ASL) with mpMRI, between propofol and sevoflurane anaesthesia","definition_or_measurement_approach":"Regional renal tissue perfusion measured by arterial spin labelling (ASL) with mpMRI."}

Sweden

Earliest CTIS Part Ii Submission Date

11-09-2025

Latest Decision Or Authorization Date

26-09-2025

Processing Time Days

15

Number Of Sites

1

Number Of Participants

50

Primary sponsor

Full Name

Region Uppsala

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden