Characterisation of Gut Microbiota, Bispectral Index Data and Plasma Kynurenine in Patients Undergoing Video-assisted Thoracic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- lung and 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 (good or poor sleepers) depending on their first postoperative night Bispectral index data. Firstly, this study aims to characterise the gut and lung microbiota in patients with lung cancer treated with surgery. Secondly, it aims to evaluate microbiota and its influence on plasma kynurenine.
详细描述
The study is a case-controlled observational trial. Sixty patients will be divided into 2 groups (good or poor sleepers) depending on their first postoperative night Bispectral index data. Firstly, this study aims to characterise the gut and lung microbiota in patients with lung cancer treated with surgery. Secondly, it aims to evaluate microbiota and its influence on plasma kynurenine.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ethnic Chinese;
- •age, 18 to 75 years old;
- •American Society of Anaesthesiologists (ASA) physical status I or II;
- •required VATS for lung surgery and one lung ventilation .
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
- •body mass index exceeding 30 kg/m2
- •Deprivation of a right to decide by an administrative or juridical entity
- •Ongoing participation or participation in another study <1 month ago
- •preoperative Pittsburgh Sleep Quality Index global scores higher than 6
- •recent (< 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics, hormonal medication, laxatives, proton pump inhibitors, insulin sensitizers or traditional Chinese medicine
研究组 & 干预措施
Group good sleepers
Duration of sleep was defined as the duration of all Bispectral Index data below 80 in the 12 hours of monitoring (from 20:00pm to 06:00am).
Sleeping time are more than six hours.
干预措施: General anesthesia (Drug)
Group poor sleepers
Duration of sleep was defined as the duration of all Bispectral Index data below 80 in the 12 hours of monitoring (from 20:00pm to 06:00am).
Sleeping time are less than two hours.
干预措施: General anesthesia (Drug)
结局指标
主要结局
lung and gut microbiota
时间窗: from baseline to postoperative 72 hours
this study will characterise the lung and gut microbiota in 2 groups of 30 patients
次要结局
- Bispectral index data(the first postoperative night)
- plasma kynurenine concentrations(baseline and the first postoperative night)
研究者
Wen-fei Tan
Professor
China Medical University, China