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CompletedNCT07455695Updated Mar 6, 2026

Temperature Changes During Sedated Pediatric Magnetic Resonance Imaging

An observational study in Body Temperature Changes, Pediatric Anesthesia and Magnetic Resonance Imaging, sponsored by Ankara Etlik City Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 1 Day to 17 Years. Per ClinicalTrials.gov, last updated 2026-03-06.

Sponsored by Ankara Etlik City Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
285
Ages
1 Day to 17 Years
Sex
All
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Study summary

Magnetic resonance imaging (MRI) is widely used in pediatric patients and frequently requires sedation or general anesthesia. Both sedation and MRI-related environmental factors may influence thermoregulation. This prospective observational study aimed to evaluate body temperature changes in children undergoing MRI under sedation and to identify factors associated with these changes. A total of 285 pediatric patients (ASA physical status I-III) were included. Tympanic body temperature was measured immediately before sedation and after completion of MRI, and the temperature difference (ΔT) was calculated. Demographic, clinical, and environmental variables were analyzed to determine predictors of temperature change.

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Conditions studied

  • Body Temperature Changes
  • Pediatric Anesthesia
  • Magnetic Resonance Imaging

Keywords

  • Pediatric Anesthesia
  • Sedation
  • Magnetic Resonance Imaging
  • Body Temperature Changes
  • Pediatric Patients
03

In context

Body Temperature Changes

97 studies on the registry are indexed under Body Temperature Changes; 20 are open to participants now.

This study's enrollment of 285 is above the median of 87 across 24 observational studies indexed under Body Temperature Changes.

Browse Body Temperature Changes studies →

Lead sponsor

Ankara Etlik City Hospital is the lead sponsor of 176 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Day to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pediatric patients younger than 18 years with ASA physical status I-III undergoing magnetic resonance imaging (MRI) under sedation between November 2023 and April 2024.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age \<18 years.
  • (ASA) physical status I-III.
  • Scheduled to undergo clinically indicated magnetic resonance imaging (MRI) under sedation.
  • Written obtained from parent.

Exclusion criteria

Exclusion Criteria:

  • Age ≥18 years.
  • IV-V.
  • Known allergy to anesthetic medications used for sedation.
  • Unstable vital signs prior to MRI.
  • Fever (body temperature ≥37.5°C) before MRI.
  • Severe pulmonary or cardiovascular comorbidities.
  • Requirement for advanced airway management (laryngeal mask airway or endotracheal intubation).
  • Refusal or absence of parental consent.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
285 participants (actual)
Patient registry
No

Interventions

  • OtherSedation During MRI

    This is a prospective observational study. No experimental intervention was applied. All pediatric patients underwent routine sedation for clinically indicated MRI procedures according to institutional standard practice. The study evaluated body temperature changes before and after MRI without modifying clinical management.

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What researchers measure

Primary outcomes

  1. Change in Body Temperature (ΔT) Before and After MRI

    The difference between tympanic body temperature measured immediately before sedation and immediately after completion of MRI (post-MRI minus pre-MRI temperature), expressed in degrees Celsius (°C).

    Time frame: From immediately before sedation to immediately after completion of MRI (approximately 20-80 minutes)

Secondary outcomes

  1. Change in Tympanic Body Temperature (ΔT)

    Change in core body temperature measured at the tympanic membrane using a Braun Thermoscan Ear Thermometer PRO 6000 (accuracy ±0.2°C). ΔT is calculated as post-MRI temperature minus pre-MRI temperature. Unit of Measure: Degrees Celsius (°C)

    Time frame: From immediately before sedation (pre-MRI) to immediately after MRI completion (approximately 20-80 minutes).

  2. Regression Coefficient (B) for Continuous Body Temperature Change (ΔT, °C)

    Independent predictors of continuous body temperature change (ΔT, °C) will be evaluated using multivariable linear regression analysis. In this model, ΔT (calculated as post-MRI minus pre-MRI tympanic temperature) will be entered as the dependent variable. The following predefined variables will be included simultaneously as independent predictors: age group (0-2, 3-7, 8-17 years), sex (male/female), ASA physical status (I-III), body mass index (kg/m²), fasting duration (hours), MRI duration (minutes), MRI room temperature (°C), MRI room humidity (%), contrast administration (yes/no), presence of comorbidity (yes/no), malignancy (yes/no), and allergy history (yes/no).

    Time frame: From immediately before sedation to immediately after completion of MRI (approximately 20-80 minutes)

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Study locations

1 site
  • Ankara Etlik City Hospital
    Altındağ, Ankara, Turkey (Türkiye)
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07455695
Responsible party
Ahmet Murat Gul (Specialist, Ankara Etlik City Hospital) — Principal investigator
First posted
Mar 6, 2026
Start date
Nov 1, 2023
Primary completion
Apr 30, 2024
Completion
Jun 30, 2024
Last update
Mar 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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