Efficacy of PLEM100(Inbody®) to Measure the the Sedation Level in Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- PLE100 score (0 to 100)
研究概览
简要总结
Evaluation of efficacy of PLEM100(Inbody®) in measuring the sedation level in pediatric patients
详细描述
The investigators plan to gather the basic data relevant to measurement of the level of consciousness/sedation in pediatric patients with developing brain by using PLEM100(Inbody®)
PLEM100 (Inbody®) is a medical equipment to measure, based on phase lag entropy algorithm, the level of patient consciousness, which is expressed by PLE score ranging from 0 (burst suppression or deep sedated) to 100 (awake).
In this study, pediatric patients aged from 3 to 6 years old who undergo total intravenous general anesthesia are chosen as target subjects. The investigators measure how PLE score changes during 1) anesthesia induction, 2) anesthesia maintenance, 3) emergence from anesthesia. Then, the PLE score would be validated by analyzing the correlation with the consciousness level expressed in University of Michigan Sedation Scale (UMSS).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients to be operated under general anesthesia, aged from 3 to 6 years
- •Written Consent is available from a parent who has been explained about the study
- •Elective surgery
排除标准
- •Patients who cannot be attached by PLEM100 (Inbody®) sensors to the forehead or the side of the head
- •Patients Having Cerebral Vascular Diseases in the past or present
- •Patients with Developmental delay
- •Patients to be admitted to intensive care unit or sedated after receiving operation
- •Patients who researchers decide are not eligible to be enrolled in the study because of various factors including clinical test results.
结局指标
主要结局
PLE100 score (0 to 100)
时间窗: baseline and end of surgery
Changes of PLE100 score
次要结局
- The level of consciousness measured in University of Michigan Sedation Scale (UMSS)(baseline and end of surgery)
- pharmacodynamic model(baseline and end of surgery)
研究者
Hee-Soo Kim
Professor
Seoul National University Hospital