Comparative Population Pharmacodynamic Modeling for Sevoflurane Effects Using Anesthetic Depth Monitoring for Sedation (ADMS) and Bispectral Index System (BIS)
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Bispectral Index (BIS)
研究概览
简要总结
The investigators want to compare the performance of anesthetic depth monitoring for sedation (ADMS) to the bispectral index (BIS) as electroencephalographic measures of sevoflurane effect using two combined sigmoidal Emax models via population pharmacodynamic approach.
详细描述
Intraoperative awareness under general anesthesia is rare, but it may cause serious psychological sequelae. Anesthetic depth monitoring system based on electroencephalography(EEG) or evoked potential are broadly used methods. Bispectral index (BIS) monitor is most popular anesthetic depth monitoring system. Anesthetic depth monitoring for sedation (ADMS) is developed in Korea as an electroencephalographic monitor for measuring the depth of anesthesia. The investigators want to compare the performance of ADMS to the bispectral index (BIS) as electroencephalographic measures of sevoflurane effect using two combined sigmoidal Emax models via population pharmacodynamic approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adult patients scheduled for an elective operation and postoperative epidural PCA with ASA physical status 1,2,3 who have signed the wrtten informed consent.
排除标准
- •preventive anticoagulation treatment
- •Significant liver, kidney, coagulation dysfunction
- •Clinically significant ECG abnormalities
- •administration of psychologic durgs or opioid within 14 days before surgery
研究组 & 干预措施
BIS group
Combined sigmoidal Emax models from the BIS data
干预措施: BIS (Device)
ADMS group
Combined sigmoidal Emax models from the ADMS data
干预措施: ADMS (Device)
结局指标
主要结局
Bispectral Index (BIS)
时间窗: Data capture will be started 45 minutes after induction of general anesthesia for 70 minutes
captured BIS data (0\~100) from the BIS system after induction of general anesthesia, sevoflurane concentrations will be progressively increased and then decreased over 70 min.
Anesthetic depth monitoring for sedation (ADMS)
时间窗: Data capture will be started 45 minutes after induction of general anesthesia for 70 minutes
captured ADMS data (0\~100) from the ADMS system after induction of general anesthesia, sevoflurane concentrations will be progressively increased and then decreased over 70 min.
次要结局
- Adverse events(visit patients 24 hours after operation.)
研究者
Seongwook Jeong
professor
Chonnam National University Hospital