EEG Analysis During Anesthesia for Day Case Gastroscopy and/or Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- Burst suppression
研究概览
简要总结
During anesthesia, EEG shows specific and significant changes according to the depth of anesthesia and the drugs used. Endoscopic procedures like gastroscopies or colonoscopies are usually done on an outpatient basis using essentially propofol for sedation or anesthesia. Preliminary reports have shown that the depth of anesthesia during these procedures may be very deep resulting even in a burst suppression pattern on the EEG.
In this study, frontal EEG will be recorded continuously using a Root - Sedline device (Masimo, US). Anesthesiologists will be free to use the medications and dosage they judge appropriate. The attending anesthesiologist will be blinded to the EEG. Medications and dosages will be recorded, as well as processed EEG data from the Sedline and the raw EEG. Primary outcome is the % of time spend in specific range of patient state index (PSI 0-10; 10-20; 20-30; 30-40; 40-50; 5-60; 60-70; 70-80; 80-90; 90-100) as well as the % of time spent in burst suppression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing gastroscopy and or colonoscopy in a outpatient setting under sedation or general anesthesia
排除标准
- •Patients < 18 years
- •altered renal function, Glomerular filtration rate < 50 mL/min/m2
- •altered hepatic tests, > 1.5 * upper normal limit
- •Any form of hepatic cirrhosis
- •Presence of oesophageal varices
- •Any neurological pathology rendering EEG analysis non reliable
研究组 & 干预措施
EEG monitoring
Continuous EEG monitoring
干预措施: EEG analysis (Diagnostic Test)
结局指标
主要结局
Burst suppression
时间窗: 90 min
Percentage of time spent in burst suppression
PSI
时间窗: 90 min
Percentage of time spent in each PSI range
次要结局
未报告次要终点
