Characterisation of Gut Microbiota in Patients Undergoing Gastrointestinal Surgery With Postoperative Delirium (GIM-POD)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Characterisation of Gut Microbiota
研究概览
简要总结
The study is a case-controlled observational trial. Sixty patients will be divided into 2 groups depending on whether postoperative delirium or not. This study aims to characterise the gut microbiota in patients undergoing gastrointestinal surgery with postoperative delirium. The CAM-ICU (Confusion Assessment Method for Intensive Care Unit) was used for delirium assessment.
详细描述
The study is a case-controlled observational trial. Sixty patients will be divided into 2 groups depending on whether postoperative delirium or not. This study aims to characterise the gut microbiota in patients undergoing gastrointestinal surgery with postoperative delirium. The CAM-ICU (Confusion Assessment Method for Intensive Care Unit) was used for delirium assessment.
General anesthesia was induced as follows: 0.3 mg kg-1 intravenous (IV) etomidate, 2 mg IV midazolam, 0.4 μg kg-1 IV sufentanil, and 0.2 mg kg-1 IV cisatracurium. Anesthesia was maintained with an end-tidal concentration of 2-3 vol% sevoflurane and 0.2-0.3 μg kg-1h-1 sufentanil to maintain the bispectral index between 40 and 60.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ethnic Chinese;
- •age, 18 to 80 years old;
- •American Society of Anaesthesiologists (ASA) physical status I or II;
- •required Gastrointestinal Surgery
排除标准
- •Cognitive difficulties
- •Partial or complete gastrectomy
- •Previous esophageal surgery
- •Previous treated by radiotherapy or surgery
- •Inability to conform to the study's requirements
- •Deprivation of a right to decide by an administrative or juridical entity
- •Ongoing participation or participation in another study <1 month ago
研究组 & 干预措施
Postoperative delirium
The CAM-ICU (Confusion Assessment Method for Intensive Care Unit) was used for delirium assessment.
干预措施: General anesthetic (Drug)
Non-Postoperative delirium
The CAM-ICU (Confusion Assessment Method for Intensive Care Unit) was used for delirium assessment.
干预措施: General anesthetic (Drug)
结局指标
主要结局
Characterisation of Gut Microbiota
时间窗: from baseline to postoperative 72 hours
this study will characterise gut microbiota in 2 groups of 30 patients
次要结局
未报告次要终点
研究者
Wen-fei Tan
clinical professor
China Medical University, China