Cross-over Analysis of Sevoflurane Insufflation and Intravenous Sedation for Radiotherapy in Pediatric Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- number of interruptions
研究概览
简要总结
aim of this cross-over study is to compare sedation with insufflated sevoflurane and intravenous sedation for pediatric radiotherapy patients
详细描述
aim of this cross-over study is to compare sedation with insufflated sevoflurane and intravenous sedation for pediatric radiotherapy(RT) patients in terms of success of the procedure (continuous completion of the RT session by providing inactivity) and complications such as desaturation, hypoventilation, airway spasm, bradycardia, tachycardia In addition, we aimed to investigate the incidence of anesthesia complications in RT patients and possible related factors with complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •undergoing radiotherapy session
排除标准
- •family refusal
- •chronic nausea and vomiting
- •apnea history, pneumonia, asthma, bronchiolitis etc. respiratory tract infection or diseases
- •cardiac disease
- •kidney failure
- •liver failure
- •anticipated difficult airway
- •metabolic diseases
- •neurological or muscular diseases.
结局指标
主要结局
number of interruptions
时间窗: during radiotherapy session
number of interruptions related to inadequate sedation and patient's movement in radiotherapy session
PSSS
时间窗: during radiotherapy session
5:Patient is moving 4: gentle immobilization for positioning. 3: do not require restraint to stop movement during the procedure. 2: Quiet (asleep or awake), not moving during procedure 1: Deeply asleep with normal vital signs, but requiring airway intervention 0: Sedation associated with abnormal physiologic parameters that require acute intervention
number of the successful radiotherapy sessions
时间窗: during radiotherapy session
succesful: radiotherapy session without interruption unsuccesful: radiotherapy session with any interruption
次要结局
- sPO2(during radiotherapy session)
- HR(during radiotherapy session)
研究者
ismail aytaç
Principal Investigator
Ankara City Hospital Bilkent