Magnetic Resonance Imaging Contrast Media Adverse ReactionNCT05423821
Non-operating Room Anesthesia Experiences in Pediatric Magnetic Resonance Imaging Cases
An observational study of Magnetic Resonance Imaging Contrast Media Adverse Reaction and Sedation Complication, run by Yunus Emre.
Trial summary
In recent years, out patient anesthesia applications have been increasing for diagnostic and interventional procedures for pediatric patients. In this study, we aimed to retrospectively analyze the anesthesia applications performed in pediatric MRI cases in our hospital. It is a retrospective study Read more about this study
- Who is it for?
- Ages 1 day to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Magnetic Resonance Imaging Contrast Media Adverse Reaction, Sedation Complication
- What is being tested?
- Anesthesia efficacy in patients undergoing MRI
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- 14 Jun 2022to 25 Jul 2022
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Cases under the age of 18 who received anesthesia outside the operating room (MRI) in our clinic between 2020-2022 will be screened retrospectively.
Who may be able to join
- Elective cases under the age of 18 will be included in the study between 01.01.2020 and 01.01.2022.
- Patients to undergo elective magnetic resonance imaging
Who cannot join
- Magnetic resonance without anesthesia will not be included. Over the age of 18 will be excluded from study
About this study
Official title: Out Patient Anesthesia Experiences in Pediatric Magnetic Resonance Imaging Cases
In recent years, out patient anesthesia applications have been increasing for diagnostic and interventional procedures for pediatric patients. In this study, we aimed to retrospectively analyze the anesthesia applications performed in pediatric MRI cases in our hospital.
It is a retrospective study
Read the detailed description
In recent years, applications with sedation and/or general anesthesia for diagnostic purposes in pediatric cases with Magnetic Resonance Imaging (MRI) method have been increasing. Although imaging methods are useful in diagnosis and treatment, they carry minimal risk for patients. As the demands for anesthesia increase during Magnetic Resonance Imaging, questions have arisen about what can be done safely in anesthesia management. The type of anesthesia applied for Magnetic Resonance Imaging is called non-operating room anesthesia.
Cross-sectional imaging techniques such as MRI require pediatric patients to remain calm for up to one hour, and thus these patients need anesthesia. In the induction of anesthesia with agents used in anesthesia outside the operating room, the patient sleeps quickly, the vital functions are stable in its maintenance, the patient recovers quickly after anesthesia, the physical and mental activities return to normal as soon as possible after recovery, and there are no side effects such as nausea, vomiting, dizziness and pain that will delay the discharge. is necessary. Sedation or general anesthesia carries risks and can have unintended consequences if poorly managed.
- Being tested
- Anesthesia efficacy in patients undergoing MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthesia efficacy in patients undergoing MRIOther
atropine will be administered when bradycardia develops, oxygen will be given if hypoxia develops
What is being measured
The primary outcome is the main question the study is designed to answer.
The type of anesthesia we trust most in magnetic resonance
genel anesthesia
Measured: two hour
Secondary outcomes (1)
reducing complications in magnetic resonance
mechanical ventilator, endtidal carbon dioxide, non-invasive oxygen saturation
Measured: two hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start14 Jun 2022 (estimated)
- Primary completion15 Jul 2022 (estimated)
- Study completion25 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnetic Resonance Imaging Contrast Media Adverse ReactionStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yunus Emre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yunus Emre, Ankara Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423821
- Sponsor's protocol ID
- ytuncdemir-MR
- Status last verified
- Jun 2022
- First submitted
- 13 Jun 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Out Patient Anesthesia Experiences in Pediatric Magnetic Resonance Imaging Cases
- ClinicalTrials.gov ID
- NCT05423821
- Acronym / sponsor ID
- ytuncdemir-MR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Yunus EmreUniversity, hospital or other
- Study start
- 14 Jun 2022 (estimated)
- Primary completion
- 15 Jul 2022 (estimated)
- Study completion
- 25 Jul 2022 (estimated)
- First posted
- 21 Jun 2022 (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.
In recent years, out patient anesthesia applications have been increasing for diagnostic and interventional procedures for pediatric patients. In this study, we aimed to retrospectively analyze the anesthesia applications performed in pediatric MRI cases in our hospital.
It is a retrospective study
Detailed description
In recent years, applications with sedation and/or general anesthesia for diagnostic purposes in pediatric cases with Magnetic Resonance Imaging (MRI) method have been increasing. Although imaging methods are useful in diagnosis and treatment, they carry minimal risk for patients. As the demands for anesthesia increase during Magnetic Resonance Imaging, questions have arisen about what can be done safely in anesthesia management. The type of anesthesia applied for Magnetic Resonance Imaging is called non-operating room anesthesia.
Cross-sectional imaging techniques such as MRI require pediatric patients to remain calm for up to one hour, and thus these patients need anesthesia. In the induction of anesthesia with agents used in anesthesia outside the operating room, the patient sleeps quickly, the vital functions are stable in its maintenance, the patient recovers quickly after anesthesia, the physical and mental activities return to normal as soon as possible after recovery, and there are no side effects such as nausea, vomiting, dizziness and pain that will delay the discharge. is necessary. Sedation or general anesthesia carries risks and can have unintended consequences if poorly managed.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Cases under the age of 18 who received anesthesia outside the operating room (MRI) in our clinic between 2020-2022 will be screened retrospectively.
Key inclusion criteria (2 listed)
- Elective cases under the age of 18 will be included in the study between 01.01.2020 and 01.01.2022.
- Patients to undergo elective magnetic resonance imaging
Key exclusion criteria (1 listed)
- Magnetic resonance without anesthesia will not be included. Over the age of 18 will be excluded from study
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 |
|---|---|---|
| Anesthesia efficacy in patients undergoing MRIatropine will be administered when bradycardia develops, oxygen will be given if hypoxia develops | Other | – |
Primary outcome
The type of anesthesia we trust most in magnetic resonance
Time frame: two hour
genel anesthesia
1 secondary outcome
reducing complications in magnetic resonance
Time frame: two hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Magnetic Resonance Imaging Contrast Media Adverse Reaction and Sedation Complication, run by Yunus Emre.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
The type of anesthesia we trust most in magnetic resonance (time frame: two hour). 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 21 Jun 2022.