Evaluation of the Development of Tolerance to Sevoflurane in Children Undergoing Repeated Anesthesia Exposure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Theta power in the EEG spectrum under anesthesia
研究概览
简要总结
Deep sedation or general anesthesia is frequently required for infant that need radiotherapy to treat malignancies. As radiation therapy usually consist of several sessions, these patients are exposure to several consecutive anesthetic exposures (e.g. for some central nervous system tumors 30 sessions of radiotherapy are required). In our center, this 30-min anesthetic exposure are with sevoflurane. Considering that repeated daily exposure to such potent drugs, as general anesthetics, may induce tolerance, it is reasonable to explore whether this phenomenon is occurring in this population.
The aim of this observational study was to determine if a repeated exposure to sevoflurane is associated with the development of clinical and electroencephalographic tolerance.
We will enroll 16 pediatric patients, and we will measure the time needed to appropriately place the laryngeal mask (clinical effect) and we also will compare the electroencephalographic signal under anesthesia across the different sessions (electroencephalographic effect).
详细描述
The purpose of this study is to evaluate the development of tolerance to sevoflurane in children undergoing repeated drug exposure.
We will evaluate the development of tolerance in two ways:
Clinical: as the time needed to perform the inhalation induction, with a standardized protocol.
Electroencephalographic: we will record every 3 sessions the electroencephalographic activity of the patients. We will perform classical spectral analysis, and coherence analysis as well.
This observational study will be mainly exploratory since there are no other previous report in this topic
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
- 10 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing radiotherapy
- •Requiring general anesthesia
排除标准
- •Previous Radiotherapy
- •Malignant Hyperthermia history
研究组 & 干预措施
Pediatric patients undergoing radiotherapy
Pediatric patients undergoing general anesthesia for radiotherapy treatment. General anesthesia will be accomplished exclusively by the administration of sevoflurane.
The inhalatory induction will be performed with sevofluorane at 8% with O2 4Lt/min. The maintenance will be with sevofluorane at an end tidal of 2.5% with 1Lt/min of O2.
The EEG will be obtain with SedLine monitor
干预措施: Sevoflurane (Drug)
结局指标
主要结局
Theta power in the EEG spectrum under anesthesia
时间窗: Last session of radiotherapy (compare to first session) - Up to 6 weeks
Theta power obtained from the EEG signal, with the patient under general anesthesia
次要结局
- Alpha power in the EEG spectrum under anesthesia(Last session of radiotherapy (compare to first session) - Up to 6 weeks)
- Time to Laryngeal Mask insertion(Last session of radiotherapy (compare to first session) - Up to 6 weeks)
- Coherence(Last session of radiotherapy (compare to first session) - Up to 6 weeks)
研究者
Rodrigo Gutiérrez
Principal Investigator
University of Chile