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临床试验/NCT07073274
NCT07073274已完成不适用

EEG Analysis During Anesthesia for Day Case Gastroscopy and/or Colonoscopy

Erasme University Hospital1 个研究点 分布在 1 个国家目标入组 149 人开始时间: 2025年7月25日最近更新:
干预措施

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

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

Other

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

研究者

发起方
Erasme University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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