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

Sponsor

China Medical University, China (Other)

Overall Status

Completed

CT.gov ID

NCT03985735

Collaborator

(none)

Enrollment

Location

5.7

Actual Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: General anesthesia

Detailed Description

Study Design

Study Type:

Observational

Actual Enrollment :

20 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 1, 2019

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Jan 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Group good sleepers 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 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.
Group poor sleepers 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.

Arm

Intervention/Treatment

Group good sleepers

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

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.

Group poor sleepers

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1. ethnic Chinese;
1. age, 18 to 75 years old;
1. American Society of Anaesthesiologists (ASA) physical status I or II;
1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	the First Hospital of China Medical University	Shenyang	Liaoning	China	110001

Sponsors and Collaborators

China Medical University, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wen-fei Tan, Professor, China Medical University, China

ClinicalTrials.gov Identifier:

NCT03985735

Other Study ID Numbers:

20190609

First Posted:

Jun 14, 2019

Last Update Posted:

Jun 22, 2020

Last Verified:

Jun 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anesthetics

Study Results

No Results Posted as of Jun 22, 2020