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

China Medical University, China

Status: Completed

Conditions: Lung Cancer

Treatments: Drug: General anesthesia

Study type: Observational

Funder types: Other

Identifiers

NCT03985735

20190609

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

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.

Treatment:

Drug: General anesthesia

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.

Treatment:

Drug: General anesthesia