Reduction of Intraoperative EEG Burst Suppression - Test of Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Chance of the total, cumulative burst suppression rate.
研究概览
简要总结
Burst suppression (BS) is a not physiological pattern in the electroencephalogram (EEG). BS during general anesthesia is mainly seen as a sign for too deep hypnosis and may increase the risk of postoperative delirium (POD), a disturbance of consciousness arising within 24 hours after surgery. This monocentric, simple masked randomized study aims primarily to investigate, whether particular anesthesiological interventions reduce the occurrence of intraoperative burst suppression. The investigator initiated trial includes 66 patients (male and female) aged ≥ 60 years in two groups (intervention and control group). Secondary aims will be the correlation of burst suppression and mean arterial pressure, concentration of anesthetics and postoperative delirium.
详细描述
Intraoperative burst suppression represents a non physiological EEG pattern. According to the literature and scientific knowledge, intraoperative burst suppression patterns might be caused either by hypotension resulting in a reduced cerebral circulation or by an oversedation of anesthetics correlating with a very deep level of hypnosis.
Some publications exist that discuss the occurrence of intraoperative burst suppression especially in elderly people (aged ≥ 60 years) as a predictor of postoperative delirium and postoperative cognitive dysfunction.
None of the studies however was able to prove a causal relationship between burst suppression and postoperative delirium. Contrary it might simply be an epiphenomenon.
Conducting this interventional trail primarily aims to prove whether specific anesthesiological interventions, such as the treatment of intraoperative hypotension in first line and/or the reduction of the concentration of anesthetics in second line, reduce intraoperative burst suppression. Hence it might be possible to investigate a possible casualty between burst suppression and postoperative delirium in a second trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Investigator)
盲法说明
Single masked. The entropy and EEG module will be masked for the responsible anesthetist as well as the study team during the entire investigation.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years
- •Surgical interventions in general anesthesia (volatile or total intravenous anesthesia)
- •expected surgery duration ≥ 1h
- •American Society of Anesthesiologists (ASA) 1-4
- •written informed consent prior to study participation
排除标准
- •Neurological or psychiatric disorders
- •hearing difficulty
- •neurosurgical (intra)cranial surgery
- •pregnancy
- •expected continuous mandatory ventilation after surgery
结局指标
主要结局
Chance of the total, cumulative burst suppression rate.
时间窗: During general anesthesia and within the intervention
The total, cumulative burst suppression rate (BSR) corresponds to area under the curve and is defined by the BSR (%) and the absolute duration of BSR (t).
次要结局
- Burst suppression rate during maintenance.(During maintenance within the intervention)
- Postoperative delirium.(Within the first three postoperative days)
- Burst suppression rate during induction.(During induction within the intervention)
- Mean arterial blood pressure.(During burst suppression within general anesthesia)
- Endtidal anesthetic concentration (ETAC) and infusion rate of propofol.(During burst suppression within the intervention)
- Specific characteristics of the EEG frequency spectrum during burst suppression(During burst suppression within general anesthesia)