About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All non-intubated patients under the age of 16 were included in the study.
Disqualifiers
Intubated pediatric patients or older than 16 years patients were excluded.
Trial population
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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Pediatric patients who received sedation for magnetic resonance imaging
Other interventionPediatric 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
Electrocardiography
Participants will be monitored with electrocardiography during the procedure and 2 hours following it.
SPO2
Participants will be monitored with pulse oximetry during the procedure and 2 hours following it.
Caphnography
Participants will be monitored with capnograph during the procedure and 2 hours following it.
Temperature Monitoring
Participants will be monitored with temperature probe during the procedure and 2 hours following it.
Sponsors and contacts
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