MR-Evaluation of Renal Function in Anesthetized Pediatric Patients

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-14
SponsorUppsala University

About this trial

The goal of this study is to investigate the effect of the anesthetic agents sevoflurane or propofol on the blood flow and oxygen delivery to the kidneys.

Pediatric patients who are planned to undergo an MRI scan with generalized anesthesia will be randomized to either IV anesthesia with propofol or inhalation anesthesia with sevoflurane. Both of these anesthetic methods are commonly used for anesthesia on an everyday basis.

In addition to the clinically indicated MRI, Multiparametric MRI will be performed to visualize the effect of the anesthetic agent on renal blood flow, perfusion and oxygenation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pediatric Patients (1 month -14 years of age)

Indicated for MRI with anesthesia

ASA (American Society of Anesthesiologists) physical status I-III

Disqualifiers

Known renal impairment or chronic kidney disease

Severe cardiac or pulmonary disease

Allergy to either Propofol or Sevoflurane

Contraindications to Magnetic Resonance Imaging

Trial design

Design model

Parallel

Treatments tested in this trial

  • Anesthesia Maintenance Agent

    Drug

    Difference in renal blood flow (RBF) between Propofol and Sevoflurane groups. Quantified by specific Multiparametric MRI metrics (e.g., (Renal blood flow by phase contrast imaging) (regional perfusion by Arterial Spin labeling (ASL) and global and regional oxygenation by Blood oxygen dependent signal (BOLD))

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: PropofolActive comparator 1 intervention
Group B: SevofluraneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Differences in RBF, as measured by phase contrast imaging with mpMRI, between propofol and sevoflurane anesthesia.

Multiparametric MRI via phase contrast imaging to quantify renal blood flow, will be standardized to renal area. By quantifying renal blood flow we will be able to evaluate the effects of propofol and sevoflurane on RBF.

Time frame
The extra imaging is expected to take 20-30 minutes.

Secondary outcomes

1

Differences in regional renal tissue perfusion, as measured by arterial spin labelling (ASL) with mpMRI, between propofol and sevoflurane anaesthesia

To investigate the effect of Propofol and Sevoflurane on regional tissue perfusion in the renal cortex and medulla.

Time frame
The whole MpMRI will take around 20-30 minutes all together where the primary and secondary outcomes can later be extracted via analysis of the images
2

Differences in regional and global renal oxygenation, as measured by Blood Oxygen Level Dependent (BOLD) signal via mpMRI, between propofol and sevoflurane anaesthesia.

To explore potential differences related to the Sevoflurane or Propofol on regional and global renal oxygenation.

Time frame
The whole MpMRI will take around 20-30 minutes all together where the primary and secondary outcomes can later be extracted via analysis of the images
3

The difference in relation of RBF to systemic non-invasive blood pressure, between propofol and sevoflurane anaesthesia

To investigate how RBF varies in relation to systemic blood pressure in paediatric patients in generalized anaesthesia with propofol or Sevoflurane.

Time frame
The entire MpMRI will take around 20-30 minutes all together where the primary and secondary outcomes can later be extracted via analysis of the images
4

The difference plasma renin concentration, measured by a blood sample, between propofol and sevoflurane anaesthesia

To explore the effect of Sevoflurane and Propofol on serum Renin concentration as a surrogate marker for Renal sympathetic nerve activation.

Time frame
1 minute

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Uppsala University

Lead sponsor

Uppsala University Hospital

Collaborator

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