Alteration of Blood-Brain-Barrier Permeability at Loss of Consciousness in Delirious Patients Recorded With Direct-Current Electroencephalography (ACDC)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 1. DC-Shift (µV/sec) in the perioperative DC-EEG.
研究概览
简要总结
With this trial we aim to characterize the intraoperative signatures of the Direct-Current-Electroencephalogram (DC-EEG) of elderly patients developing a PostOperative Delirium (POD) compared to patients who do not develop a POD. We hereby intend to gain a better understanding of the electrical potential at the blood-brain-barrier (measured with DC-EEG) during general anaesthesia. Second, we want to study the effect of age on the DC-EEG by comparing a younger (18-30y) to an elderly cohort (>70). Third, we aim to couple the DC-EEG signatures to blood sample analysis in order to understand the relationship between metabolic, inflammatory and vascular reaction with the intraoperative DC-EEG.
详细描述
In order to study the intraoperative DC-EEG signatures of elderly patients coupled with lab data to evaluate the role of the age-dependent blood-brain barrier (BBB) dysfunction in general anesthesia and its meaning in POD pathophysiology following protocol will be followed:
- On the day of the surgery the 21 DC-EEG sintered Ag/AgCl (silver chloride) electrodes will be placed before the start of anesthesia following the 10-20-system.
- The first blood sample will be collected via the routinely placed intravenous catheter.
- During the induction of anesthesia special care will be given to the exact time of loss of consciousness (LOC), defined with the suppression of the lid closure reflex.
- Markers will be set at important time points of the anesthetic care (Baseline, start of analgesia/anesthesia, LOC, intubation, beginning of surgical procedure, end of anesthesia, regain of consciousness, extubation, admission recovery room).
- Shortly after consciousness has vanished (5-10 minutes), a second blood sample will be drawn.
- The DC-EEG recording will last until one hour after arrival at the recovery room, during which NuDesc score will be assessed every 15 minutes.
- A third blood sample is to be collected in the recovery room. In the five days following surgery patients will be visited in the morning and in the evening to screen delirious symptoms with the help of standardized scores (NuDesc, DSM V, DDS). If patients are staying on the intensive care unit the CAM-ICU will be used.
Blood sample analysis will include blood cells count, electrolytes, inflammatory markers, cholesterols, proteins, structural BBB markers and markers of neuronal damage.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged >70 years OR between 18 and 30
- •Planned operation time >1 hour
- •Expected hospital treatment period of 5 days,
- •Anesthesia induction, anesthesia maintenance with either Propofol or an inhalative anesthetic agent as Sevoflurane or Desflurane,
- •The ability to give informed consent
排除标准
- •Age under 18 or between 31 and 69
- •Patients with a history of neurological or psychiatric disorders
- •Planned neurosurgery
- •Current medication of tranquilizers / antidepressants
- •Isolation of patients with multi-resistant Bacteria
- •Inability of the patients to speak and/or read German
- •Intraoperative use of ketamine, N²O, Etomidate or Dexmedetomidine
- •Participation in a prospective interventional trial
结局指标
主要结局
1. DC-Shift (µV/sec) in the perioperative DC-EEG.
时间窗: From the beginning of general anaesthesia to one hour after regain of consciousness
Full-brain DC-EEG with 21 electrodes placed preoperatively following the 10/20-System and recording until one hour after regain of consciousness.
次要结局
- Duration of Delirium(Participants will be followed for the duration of hospital stay, or maximal until postoperative day 5)
- Peri-operative, full-brain overall EEG band power(Up to the end of stay in the recovery room)
- Incidence of Postoperative Delirium(Patients will be follow until hospital discharge, or maximal until postoperative day 5)
- DC-EEG signatures in young (18-30) vs. elderly (>70) patients(From the beginning of general anaesthesia to one hour after regain of consciousness)
- Analysis of pre-, intra- and postoperative blood parameters(: From shortly before the beginning of general anaesthesia to maximum one hour after arrival in the recovery room)
- Burst suppression duration(During anesthesia procedure)
- Additional perioperative DC-EEG signatures: morphology, polarity (positive/negative), amplitude (µV)(From the beginning of general anaesthesia to one hour after regain of consciousness)
- Intensive care unit length of stay(Participants will be followed for the duration of intensive care unit stay, an expected average of 5 days)
- Hospital length of stay(Participants will be followed for the duration of hospital stay, an expected average of 7 days)
研究者
Claudia Spies
Head of the Department of Ansthesiology and Operative Intensive Care Medicine, Charité - Universitätsmedizin Berlin
Charite University, Berlin, Germany