MRI Assesment of Cerebral Blood Flow in Anesthetized Children

NCT06886698 | Not Yet Recruiting

• 2 other identifiers: K 2025-0337Region Stockholm
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Children undergoing magnetic resonance imaging (MRI) of the brain often need to be sedated to complete the examination, as it is difficult to remain still for a long period, which is required to obtain usable images. During sedation, most patients typically experience a drop in blood pressure, including children. Maintaining an adequate blood pressure under anesthesia is important, as blood pressure is routinely used as a measure to ensure sufficient blood circulation to the body's organs, including the brain. Ensuring adequate blood flow to the brain is one of the cornerstones of all anesthesia, including in children. Therefore, low blood pressure during anesthesia is often treated with standardized interventions, such as blood pressure-raising interventions. These treatments generally restore blood pressure to normal, but how this affects blood flow to the brain in children is not fully known. With the help of modern MRI technology (so-called Arterial Spin Labeling, ASL), blood flow in the brain can be measured quickly and completely safely with high precision. In similar situations with adult patients, it has been observed that while blood pressure-raising interventions successfully normalize low blood pressure, MRI scans show that blood flow to the brain paradoxically decreases despite the increase in blood pressure. It is believed that this may be due to the brain's blood vessels constricting. The investigators now wish to examine this relationship in sedated children undergoing planned brain MRI for certain diagnoses. The investigators hypothesis is that standardized measures intended to raise blood pressure (i.e., the routine treatment used regardless of whether a patient participates in the study or not) normalizes low blood pressure (when deemed necessary to treat according to routine) but does not necessarily lead to improved blood flow to the brain. Primary research question: How does routine treatment of low blood pressure affect cerebral blood flow in sedated children?

Conditions

Blood Flow; Cerebral Oxygenation; Blood Pressure

Keywords

anesthesia; bloodflow; brain; children

Outcome Measures

Primary Outcomes (1)

• Changes in cerebral blood flow in response to hypotension treatment

  Quantification of cerebral blood flow using Arterial Spin Labeling during hypotension and subsequently in response to standardized treatment of hypotension as per departmental standard operating procedure.

  From detection of hypotension to assessment of immediate change in cebrebral bloodflow, data reported after approximately one year

Study Arms (1)

pediatric MRI

Patients scheduled for brain MRI under anesthesia, aged 6 months to 12 years.

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for brain MRI under anesthesia, aged 6 months to 12 years

You may qualify if:

• children aged 6 months to 12 years
• Planned to undergo MRI brain

You may not qualify if:

• known brain tumor
• vascular malformation in the brain
• hydrocephalus

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

Karolinska University Hospital

Solna, 171 64, Sweden

Location

Study Officials

• Jacob Karlsson, MD PhD Associate Professor

  Karolinska Universitets Sjukhuset

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacob Karlsson, MD PhD Associate Professor

CONTACT

+46737145217; jacob.karlsson.1@ki.se

Per-Arne Lönnqvist, Professor

CONTACT

+46812370000; per-arne.lönnqvist@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 20, 2025
• Study Start: April 15, 2025
• Primary Completion: April 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

SE (1)