Frequency of Adverse Events in Pediatric Patients Receiving Sedation for Magnetic Resonance Imaging
NCT Number: NCT06467045
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Sedation|Pediatric Anesthesia|Magnetic Resonance Imaging|Adverse Effect
Interventions: OTHER: Pediatric patients who received sedation for magnetic resonance imaging
Sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sex: ALL
Age: CHILD
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-24
Completion Date: 2024-10-05
Locations: Sisli Hamidiye Etfal Research and Training Hospital, Istanbul, Sarıyer, 34060, Turkey

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.

Primary Outcome Measures: 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 Outcome Measures: Electrocardiography, Participants will be monitored with electrocardiography during the procedure and 2 hours following it., 3 hours|SPO2, Participants will be monitored with pulse oximetry during the procedure and 2 hours following it., 3 hours|Caphnography, Participants will be monitored with capnograph during the procedure and 2 hours following it., 3 hours|Temperature Monitoring, Participants will be monitored with temperature probe during the procedure and 2 hours following it., 3 hours|Systolic and Diastolic blood pressure, Participants will be monitored with blood pressure monitoring during the procedure and 2 hours following it., 3 hours|Glasgow Coma Scale, Participants will be followed with glaskow coma scale during the procedure and 2 hours following it. Minimum value is 3 and maximum value is 15., 3 hours|Aldrete Score, Participants will be assessed for recovery using the Aldrete score during the 2-hour follow-up period after the procedure. Minimum value is 0 and maximum value is 10., 2 hours