Frequency of Adverse Events in Pediatric Patients Receiving Sedation for Magnetic Resonance Imaging

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-16
SponsorSisli Hamidiye Etfal Training and Research Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Pediatric patients who received sedation for magnetic resonance imaging

    Other intervention

    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.

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Pediatric patients who received sedation for magnetic resonance imaging1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 hours
2

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.

Time frame
2 hours

Secondary outcomes

1

Electrocardiography

Participants will be monitored with electrocardiography during the procedure and 2 hours following it.

Time frame
3 hours
2

SPO2

Participants will be monitored with pulse oximetry during the procedure and 2 hours following it.

Time frame
3 hours
3

Caphnography

Participants will be monitored with capnograph during the procedure and 2 hours following it.

Time frame
3 hours
4

Temperature Monitoring

Participants will be monitored with temperature probe during the procedure and 2 hours following it.

Time frame
3 hours

Other outcomes

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