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临床试验/NCT06467045
NCT06467045招募中不适用

Frequency of Adverse Events and Factors Causing Adverse Events in Pediatric Patients Receiving Sedation for Magnetic Resonance Imaging: Observational Study

Sisli Hamidiye Etfal Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年6月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
1
主要终点
Postoperative adverse events

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
0 Days 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All non-intubated patients under the age of 16 were included in the study.

排除标准

  • Intubated pediatric patients or older than 16 years patients were excluded.

结局指标

主要结局

Postoperative adverse events

时间窗: 2 hours

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.

Perioperative adverse events

时间窗: 1 hours

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.

次要结局

  • Electrocardiography(3 hours)
  • Temperature Monitoring(3 hours)
  • Caphnography(3 hours)
  • Aldrete Score(2 hours)
  • SPO2(3 hours)
  • Systolic and Diastolic blood pressure(3 hours)
  • Glasgow Coma Scale(3 hours)

研究者

发起方
Sisli Hamidiye Etfal Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kubra OZTURK

principal investigator, medical doctor, anesthesiology and reanimation

Sisli Hamidiye Etfal Training and Research Hospital

研究点 (1)

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