Ignite Creation Date:
2024-07-17 @ 10:53 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06467045
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-12
Brief Title:
Frequency of Adverse Events in Pediatric Patients Receiving Sedation for Magnetic Resonance Imaging
Sponsor:
Sisli Hamidiye Etfal Training and Research Hospital
Organization:
Sisli Hamidiye Etfal Training and Research Hospital
Study Overview
Official Title:
Frequency of Adverse Events and Factors Causing Adverse Events in Pediatric Patients Receiving Sedation for Magnetic Resonance Imaging Observational Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
IntroductionThe 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 19062024 and 16092024 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
Methods Between 19062024 and 16092024 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
Detailed Description:
In modern times the application of anesthesia outside the operating room is increasingly common in pediatric patients for day procedures and imaging by clinics such as gastroenterology cardiology oncology and radiology In addition to the difficulty of airway control in pediatric patients the risks increase in non-operating room settings due to the unfamiliarity of the environment and being far from the operating room Moreover anesthesia application is risky due to patient-independent reasons such as the insufficient number of auxiliary staff the inadequate emergency experience of the personnel in the units and the limited number and variety of materials Therefore anesthesia application in pediatric patients is specialized and requires an experienced anesthesia team
MRI imaging is a noisy long-lasting technique that must be performed motionless Pediatric patients requiring MRI imaging often have congenital anomalies accompanying diseases and acquired diseases due to birth trauma Additionally the complication rate related to the procedure may increase with a cooperative mobile child For this reason day procedures in pediatric patients should be performed under sedation
Some of the undesirable side effects encountered after sedation in pediatric patients include nausea vomiting cough laryngospasm bronchospasm pulmonary aspiration allergic reactions anaphylaxis extravasation neurological damage cardiovascular instability and cardiac arrest Although serious side effects are rarely encountered minor undesirable side effects are frequently encountered Many studies emphasize that serious undesirable side effects following sedation and general anesthesia in children are respiratory complications
In our country pediatric anesthesia applications outside the operating room are performed in a limited number of centers Although there are retrospective studies on pediatric patients undergoing magnetic resonance imaging under sedation in the literature it has been observed that there is insufficient data on large-scale observational studies
The hypothesis of the study is that the frequency of anesthesia-related adverse effects is high in pediatric patients sedated in non-operating room environments The primary aim of our study is to determine the frequency of adverse events in pediatric patients sedated for magnetic resonance imaging Secondly the investigators aimed to identify the factors causing these adverse events
MRI imaging is a noisy long-lasting technique that must be performed motionless Pediatric patients requiring MRI imaging often have congenital anomalies accompanying diseases and acquired diseases due to birth trauma Additionally the complication rate related to the procedure may increase with a cooperative mobile child For this reason day procedures in pediatric patients should be performed under sedation
Some of the undesirable side effects encountered after sedation in pediatric patients include nausea vomiting cough laryngospasm bronchospasm pulmonary aspiration allergic reactions anaphylaxis extravasation neurological damage cardiovascular instability and cardiac arrest Although serious side effects are rarely encountered minor undesirable side effects are frequently encountered Many studies emphasize that serious undesirable side effects following sedation and general anesthesia in children are respiratory complications
In our country pediatric anesthesia applications outside the operating room are performed in a limited number of centers Although there are retrospective studies on pediatric patients undergoing magnetic resonance imaging under sedation in the literature it has been observed that there is insufficient data on large-scale observational studies
The hypothesis of the study is that the frequency of anesthesia-related adverse effects is high in pediatric patients sedated in non-operating room environments The primary aim of our study is to determine the frequency of adverse events in pediatric patients sedated for magnetic resonance imaging Secondly the investigators aimed to identify the factors causing these adverse events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None