Body Temperature ChangesNCT07455695
Temperature Changes During Sedated Pediatric Magnetic Resonance Imaging
An observational study of Body Temperature Changes and Pediatric Anesthesia, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 17 years
- Conditions the study is for
- Body Temperature Changes, Pediatric Anesthesia, Magnetic Resonance Imaging
- What is being tested?
- Sedation During MRI
- How many people
- 285 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Age <18 years.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Scheduled to undergo clinically indicated magnetic resonance imaging (MRI) under sedation.
- Written informed consent obtained from parent.
Who cannot join
- Age ≥18 years.
- ASA physical status 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Body Temperature Changes in Children Undergoing Magnetic Resonance Imaging Under Sedation
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.
- Being tested
- Sedation During MRI
- Keywords
- Pediatric Anesthesia, Sedation, Magnetic Resonance Imaging, Body Temperature Changes, Pediatric Patients
- Medical subject headings
- Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedation During MRIOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From immediately before sedation to immediately after completion of MRI (approximately 20-80 minutes)
Secondary outcomes (2)
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)
Measured: From immediately before sedation (pre-MRI) to immediately after MRI completion (approximately 20-80 minutes).
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).
Measured: From immediately before sedation to immediately after completion of MRI (approximately 20-80 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 Nov 2023
- Primary completion30 Apr 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Temperature ChangesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ahmet Murat Gul, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455695
- Sponsor's protocol ID
- AEŞH-EK1-2023-555
- Status last verified
- Mar 2026
- First submitted
- 22 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Temperature Changes in Children Undergoing Magnetic Resonance Imaging Under Sedation
- ClinicalTrials.gov ID
- NCT07455695
- Acronym / sponsor ID
- AEŞH-EK1-2023-555
- Keywords
- Pediatric Anesthesia, Sedation, Magnetic Resonance Imaging, Body Temperature Changes, Pediatric Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- Age <18 years.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Scheduled to undergo clinically indicated magnetic resonance imaging (MRI) under sedation.
- Written informed consent obtained from parent.
Key exclusion criteria (8 listed)
- Age ≥18 years.
- ASA physical status IV-V.
- Known allergy to anesthetic medications used for sedation.
- Unstable vital signs prior to MRI.
- Fever (body temperature ≥37.5°C) before MRI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sedation During MRIThis 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. | Other | – |
Primary outcome
Change in Body Temperature (ΔT) Before and After MRI
Time frame: From immediately before sedation to immediately after completion of MRI (approximately 20-80 minutes)
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).
2 secondary outcomes
Change in Tympanic Body Temperature (ΔT)
Time frame: From immediately before sedation (pre-MRI) to immediately after MRI completion (approximately 20-80 minutes).
Regression Coefficient (B) for Continuous Body Temperature Change (ΔT, °C)
Time frame: From immediately before sedation to immediately after completion of MRI (approximately 20-80 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
Related trials for Body Temperature Changes
Not yet recruitingPhase 1/2
Effect of Temperature Elevation on the Antimicrobial Efficacy of Two Root Canal Irrigants in Primary Root Canal Infections: A Randomized Controlled Clinical Trial
Irreversible Pulpitis
RecruitingObservational study
Diagnosis and Management of Inflammatory and Infectious Diseases
Infection, Inflammation
Recruiting
Role of Hypothermia in Endovascular Stroke Thrombectomy
Stroke, Acute Ischemic
Recruiting
Thermal Therapies in the Treatment of Muscle Injuries
Hamstring Injuries, Hamstring Muscle Repair
Not yet recruiting
Accuracy of Moni-Patch Compared With Tympanic Temperature Monitoring in Adults at Risk of Fever
Fever, Temperature Monitoring
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Body Temperature Changes and Pediatric Anesthesia, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Temperature (ΔT) Before and After MRI (time frame: From immediately before sedation to immediately after completion of MRI (approximately 20-80 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.