MR-Evaluation of Renal Function in Anesthetized Pediatric Patients

NCT ID: NCT06876870

Last Updated: 2025-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2027-06-20

Brief Summary

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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.

Detailed Description

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See the study protocol

Conditions

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Renal Blood Flow Anesthesia MRI Renal Oxygenation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients are randomized to one out of two possible methods of maintenance anesthesia
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors
The analyzer of the MRI images of renal blood flow, quantifying volumes will be masked from the method of anesthesia.

Study Groups

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Propofol

Propofol Maintenance Anesthesia

Group Type ACTIVE_COMPARATOR

Anesthesia Maintenance Agent

Intervention Type 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))

Sevoflurane

Sevoflurane Maintenance Anesthesia

Group Type ACTIVE_COMPARATOR

Anesthesia Maintenance Agent

Intervention Type 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))

Interventions

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Anesthesia Maintenance Agent

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))

Intervention Type DRUG

Other Intervention Names

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Anesthesia Sevoflurane Propofol

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

1 Month

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University Hospital

OTHER

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Frithiof, Professor

Role: STUDY_CHAIR

Istitution of Surgical Sciences, Anesthesiology and Intensive Care

Central Contacts

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Arash Emami, PhD student

Role: CONTACT

+46763222722

Robert Frithiof, Professor

Role: CONTACT

Other Identifiers

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2025-520627-25-00

Identifier Type: CTIS

Identifier Source: secondary_id

MERAPED

Identifier Type: -

Identifier Source: org_study_id

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