MR-Evaluation of Renal Function in Anesthetized Pediatric Patients

NCT06876870 | Not Yet Recruiting Phase 4

• 2 other identifiers: MERAPED2025-520627-25-00
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Renal Blood Flow; Anesthesia; MRI; Renal Oxygenation

Keywords

Renal Blood flow; Anesthesia; Pediatric; MRI

Outcome Measures

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.

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

Secondary Outcomes (4)

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

  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

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

  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

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

  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

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

  1 minute

Study Arms (2)

Propofol

ACTIVE COMPARATOR

Propofol Maintenance Anesthesia

Drug: Anesthesia Maintenance Agent

Sevoflurane

ACTIVE COMPARATOR

Sevoflurane Maintenance Anesthesia

Drug: Anesthesia Maintenance Agent

Interventions

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))

Also known as: Anesthesia, Sevoflurane, Propofol

Propofol; Sevoflurane

Eligibility Criteria

• Age: 1 Month - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric Patients (1 month -14 years of age)
• Indicated for MRI with anesthesia
• ASA (American Society of Anesthesiologists) physical status I-III

You may not qualify if:

• Known renal impairment or chronic kidney disease
• Severe cardiac or pulmonary disease
• Allergy to either Propofol or Sevoflurane
• Contraindications to Magnetic Resonance Imaging
• Contraindications to either Propofol or Sevoflurane
• Declined participation or declined consent from patients, parents or guardians
• Ongoing acute kidney injury

Sponsors & Collaborators

• Uppsala University: lead
• Uppsala University Hospital: collaborator

MeSH Terms

Interventions

Anesthesia; Sevoflurane; Propofol

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Robert Frithiof, Professor

  Istitution of Surgical Sciences, Anesthesiology and Intensive Care

  STUDY CHAIR

Central Study Contacts

Arash Emami, PhD student

CONTACT

+46763222722; arash.emami@uu.se

Robert Frithiof, Professor

CONTACT

robert.frithiof@uu.se

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The analyzer of the MRI images of renal blood flow, quantifying volumes will be masked from the method of anesthesia.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients are randomized to one out of two possible methods of maintenance anesthesia

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 10, 2026
• Study Completion (Estimated): June 20, 2027
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share