Frequency of Adverse Events in Pediatric Patients Receiving Sedation for Magnetic Resonance Imaging
Frequency of Adverse Events and Factors Causing Adverse Events in Pediatric Patients Receiving Sedation for Magnetic Resonance Imaging: Observational Study
1 other identifier
observational
500
1 country
1
Brief Summary
Introduction:The application of anesthesia outside the operating room for pediatric patients has increased in recent years. For diagnostic and treatment follow-up purposes, magnetic resonance imaging (MRI) requires the pediatric patient to remain still, necessitating sedation. The study aimed to determine the frequency of adverse effects and influencing factors in pediatric patients undergoing sedation during MRI. Methods: Between 19.06.2024 and 16.09.2024, estimated 500 pediatric patients who underwent MRI under sedation will be prospectively observed. All non-intubated patients under the age of 16 will be included in the study. The demographic data, comorbidities, and medications of the patients, the procedures performed, the anesthetic drugs used, the expertise duration of the anesthesiologist, and the adverse effects encountered will be recorded.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2024
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2024
CompletedFirst Posted
Study publicly available on registry
June 20, 2024
CompletedStudy Start
First participant enrolled
June 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 21, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 5, 2024
CompletedJune 25, 2024
June 1, 2024
3 months
June 12, 2024
June 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Perioperative adverse events
In the study, the investigators will record the adverse effects includes respiratory, circulatory, neurological systems observed during the procedure. Respiratory adverse effects includes bronchospasm, laryngospasm, apnea, pulmonary aspiration, anaphylaxis. Circulatory system adverse affects includes hypotension, hypertension, cardiac arrest. In the study, neurological side effects such as glasgow coma scale impairment and convulsions will be recorded.
1 hours
Postoperative adverse events
In the study, the investigators will record the adverse effects includes respiratory, circulatory, neurological systems the 2 hours following the procedure. Respiratory adverse effects includes bronchospasm, laryngospasm, apnea, pulmonary aspiration, anaphylaxis. Circulatory system adverse affects includes hypotension, hypertension, cardiac arrest. In the study, neurological side effects such as glasgow coma scale impairment and convulsions will be recorded.
2 hours
Secondary Outcomes (7)
Electrocardiography
3 hours
SPO2
3 hours
Caphnography
3 hours
Temperature Monitoring
3 hours
Systolic and Diastolic blood pressure
3 hours
- +2 more secondary outcomes
Study Arms (1)
Pediatric patients who received sedation for magnetic resonance imaging
All pediatric patients who received sedation for magnetic resonance imaging(MRI) in radiology unit will be added to this study. In the study, there is only one group. No comparisons are being made.
Interventions
Pediatric patients who underwent MRI under sedation will be prospectively observed. All non-intubated patients under the age of 16 will be included in the study. The demographic data, comorbidities, and medications of the patients, the procedures performed, the anesthetic drugs used, the expertise duration of the anesthesiologist, and the adverse effects encountered will be recorded.
Eligibility Criteria
500 patients non-intubated under the age of 16 who underwent magnetic resonance imaging under sedation in the radiology unit will be included in the study.
You may qualify if:
- All non-intubated patients under the age of 16 were included in the study.
You may not qualify if:
- Intubated pediatric patients or older than 16 years patients were excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sisli Hamidiye Etfal Research and Training Hospital
Istanbul, Sarıyer, 34060, Turkey (Türkiye)
Related Publications (2)
Cosgrove P, Krauss BS, Cravero JP, Fleegler EW. Predictors of Laryngospasm During 276,832 Episodes of Pediatric Procedural Sedation. Ann Emerg Med. 2022 Dec;80(6):485-496. doi: 10.1016/j.annemergmed.2022.05.002. Epub 2022 Jun 23.
PMID: 35752522RESULTHabre W, Disma N, Virag K, Becke K, Hansen TG, Johr M, Leva B, Morton NS, Vermeulen PM, Zielinska M, Boda K, Veyckemans F; APRICOT Group of the European Society of Anaesthesiology Clinical Trial Network. Incidence of severe critical events in paediatric anaesthesia (APRICOT): a prospective multicentre observational study in 261 hospitals in Europe. Lancet Respir Med. 2017 May;5(5):412-425. doi: 10.1016/S2213-2600(17)30116-9. Epub 2017 Mar 28.
PMID: 28363725RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator, medical doctor, anesthesiology and reanimation
Study Record Dates
First Submitted
June 12, 2024
First Posted
June 20, 2024
Study Start
June 24, 2024
Primary Completion
September 21, 2024
Study Completion
October 5, 2024
Last Updated
June 25, 2024
Record last verified: 2024-06