Clinical trial · Observational
Characterisation of Gut Microbiota, Bispectral Index Data and Plasma Kynurenine in Patients Undergoing Video-assisted Thoracic Surgery
NCT03985735CI-TRIAL-00045623completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| General anesthesia | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Group good sleepers
- description
- 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.
- interventionNames
- Drug: General anesthesia
- label
- Group poor sleepers
- description
- 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.
- interventionNames
- Drug: General anesthesia
Primary outcomes (1)
- measure
- lung and gut microbiota
- timeFrame
- from baseline to postoperative 72 hours
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.