The Impact of Electroencephalogram (EEG) - Guided Inhalational Anesthetic Control on the Occurrence of EEG Discontinuity in Infants: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- EEG discontinuity
研究概览
简要总结
This study is a randomized controlled trial to evaluate whether EEG-guided calibration of inhalation agents can reduce occurrence of EEG discontinuity in infants during general anesthesia.
详细描述
This is a study for comparison of incidence of EEG discontinuity during general anesthesia using sevoflurane. EEG guidance group will receive calibration of fraction of inhalational sevoflurane according to components of slow wave and delta wave of raw EEG. Control group will receive conventional management of anesthesia according to vital signs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants who were born as full-term (>37 weeks postconception) and are equal to or less than 12 month old who were scheduled to undergo surgery under general anesthesia using inhalation agents.
- •Belongs to American Society of Anesthesiologists Physical Status 1 or 2
排除标准
- •Infants who were born less than 37 weeks postconception or has history of mechanical ventilation immediately after birth
- •Presence of any genetic disease, chromosomal anomaly or congenital anomaly that can affect brain development
- •Presence of any disease or disability in central nervous system
- •History of trauma at head or surgery on brain
- •History of hypersensitivity to any anesthetic agents
- •Status of sedation or endotracheal intubation before induction of anesthesia
- •Inability to attach probes for EEG monitoring
- •Expectation of operation time as less than 5 minutes
- •Other conditions that researchers regard as inappropriate for enrollment
结局指标
主要结局
EEG discontinuity
时间窗: From start of anesthesia to end of anesthesia, Less than 24 hours
Incidence of EEG discontinuity (EEG amplitudes \< 25uV for more than 2 seconds)
次要结局
- SEF(From start of anesthesia to end of study, Less than 24 hours)
- PSi(From start of anesthesia to end of study, Less than 24 hours)
- Heart rate(From start of anesthesia to end of study, Less than 24 hours)
- Total duration of EEG discontinuity(From start of anesthesia to end of study, Less than 24 hours)
- EtSev(From start of anesthesia to end of study, Less than 24 hours)
- Significant isoelectric EEG(From start of anesthesia to end of study, Less than 24 hours)
- Mean blood pressure(From start of anesthesia to end of study, Less than 24 hours)
研究者
Ji-Hyun Lee
Clinical Associate Professor
Seoul National University Hospital