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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03985735
• Other study ID #: 20190609
• Status: Completed
• Start date: August 1, 2019
• Est. completion date: January 20, 2020

Study information

• Verified date: June 2020
• Source: China Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 20, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer

Intervention

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.

Locations

Country	Name	City	State
China	the First Hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Bispectral index data	this study will characterise the Bispectral index data in 2 groups of 30 patients	the first postoperative night
Secondary	plasma kynurenine concentrations	this study will characterise the plasma kynurenine concentrations in 2 groups of 30 patients	baseline and the first postoperative night