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

Completed

• Conditions: Lung Cancer
• Interventions: Drug: General anesthesia

• Registration Number: NCT03985735
• Lead Sponsor: China Medical University, China

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.

Study Timeline

• Study First Submitted: 2019-06-07
• Study First Submitted QC: 2019-06-08
• Study First Posted: 2019-06-14
• Study Start: 2019-08-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-01-20
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-18
• Last Update Posted: 2020-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group good sleepers	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 more than six hours.
Group poor sleepers	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

the First Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China