Effects of Different Sevoflurane Concentrations on Intraoperative EEG and Postoperative Delirium in Elderly Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 460
- 试验地点
- 1
- 主要终点
- Incidence of POD
研究概览
简要总结
Delirium is an acute onset of attentional and cognitive impairment. BIS guided anesthesia can reduce the incidence of postoperative delirium. Long term electroencephalogram (EEG) suppression during operation is related to postoperative delirium. The latest research shows that the anesthesia depth guided by EEG does not reduce the incidence of postoperative delirium. The purpose of this study was to explore the relationship between anesthesia exposure with different minimum alveolar concentration(MAC) and postoperative delirium(POD), and to observe the characteristics of EEG.
详细描述
More and more studies have focused on the relationship between EEG inhibition and postoperative delirium in general anesthesia. At present, there are two kinds of commonly processed quantitative EEG monitoring to evaluate the depth of anesthesia, one is bispectral index (BIS) and the other is patient state index (PSI). The relationship between intraoperative anesthetic exposure and postoperative delirium is unclear, or whether potential patient characteristics increase the risk of EEG suppression and postoperative delirium.
Gastrointestinal surgery can lead to long-term changes in colonic flora, which can remotely regulate brain function through the gut brain axis. We speculated that the abnormal composition of intestinal flora before abdominal operation might be the influencing factor of POD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of gastrointestinal diseases
- •Patients were aged 60 to 90 years
- •American Society of Anesthesiologists (ASA) risk classification II-IV
- •Patients were scheduled to undergo elective major abdominal operation(with a anticipated time of 2-6 h)
排除标准
- •Preoperative dementia or cognitive impairment
- •Mental instability or mental illness
- •Patients with any factors affecting cognitive assessment, such as language, vision and hearing impairment
- •Any cerebrovascular accident occurred within 3 months, such as stroke etc
- •Previous history of delirium
- •Known hypersensitivity to sevoflurane or history of malignant hyperthermia
- •Abuse of narcotic sedative and analgesic drugs
- •Those who have reoperation within 7 days after operation
研究组 & 干预措施
light general anesthesia
During anesthesia maintenance, patients were received with low concentration sevoflurane to maintain a target of 0.8 MAC.
干预措施: Low MAC (Drug)
deep general anesthesia
During anesthesia maintenance, patients were received with high concentration sevoflurane to maintain a target of 1.0 MAC.
干预措施: High MAC (Drug)
结局指标
主要结局
Incidence of POD
时间窗: The 7th day after the surgery
Incidence of POD after surgery
次要结局
- EEG burst inhibition(During surgery)
- Incidence of adverse events(30-day after surgery)
- 30-day mortality(30-day after surgery)
- length of stay(From 1st day after the surgery to 2 weeks)