Characterisation of Gut Microbiota, Bispectral Index Data and Plasma Kynurenine in Patients Undergoing Video-assisted Thoracic Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Characterisation of Gut Microbiota, Bispectral Index Data and Plasma Kynurenine in Patients Undergoing Video-assisted Thoracic Surgery

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: General anesthesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group good sleepers<br>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. | Drug: General anesthesia<br>* 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.<br>|
| Group poor sleepers<br>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. | Drug: General anesthesia<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lung and gut microbiota | this study will characterise the lung and gut microbiota in 2 groups of 30 patients | from baseline to postoperative 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bispectral index data | this study will characterise the Bispectral index data in 2 groups of 30 patients | the first postoperative night | 
| plasma kynurenine concentrations | this study will characterise the plasma kynurenine concentrations in 2 groups of 30 patients | baseline and the first postoperative night |