An observational study in Lung Cancer, sponsored by China Medical University, China. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-06-22.
Sponsored by China Medical University, China · Observational
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.
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.
China Medical University, China is the lead sponsor of 93 studies on the registry; 34 are open to participants now.
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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.
Exclusion Criteria:
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
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
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.
lung and gut microbiota
this study will characterise the lung and gut microbiota in 2 groups of 30 patients
Time frame: from baseline to postoperative 72 hours
Bispectral index data
this study will characterise the Bispectral index data in 2 groups of 30 patients
Time frame: the first postoperative night
plasma kynurenine concentrations
this study will characterise the plasma kynurenine concentrations in 2 groups of 30 patients
Time frame: baseline and the first postoperative night
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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China Medical University, China