Lung Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGGeneral anesthesia
For maintenance of propofol anesthesia, total intravenous anesthesia was administered by using propofol (Fresenius Kabi, Austria GmbH) at a plasma target concentration (Marsh pharmacokinetic model software) of 2.5-4 μg/ml. Remifentanil (0.2-0.5 μg/kg/min) was given to all patients during the operation. Additional cisatracurium （0.05 mg/kg）and fentanyl (30-50 μg at the end of surgery) were used as needed, in accordance with the clinical requirements.
Sponsors
China Medical University, China
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 1\. ethnic Chinese; * 2\. age, 18 to 75 years old; * 3\. American Society of Anaesthesiologists (ASA) physical status I or II; * 4\. required VATS for lung surgery and one lung ventilation .
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| lung and gut microbiota | from baseline to postoperative 72 hours | this study will characterise the lung and gut microbiota in 2 groups of 30 patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bispectral index data | the first postoperative night | this study will characterise the Bispectral index data in 2 groups of 30 patients |
| plasma kynurenine concentrations | baseline and the first postoperative night | this study will characterise the plasma kynurenine concentrations in 2 groups of 30 patients |
Countries
China
Outcome results
None listed