Characterisation of Gut Microbiota, Bispectral Index Data and Plasma Kynurenine in Patients Undergoing Thyroid Surgery

Study Overview
=================
Brief Summary
-----------------
The study is a case-controlled observational trial. Forty 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 lung microbiota in patients treated with thyroid surgery. Secondly, it aims to evaluate microbiota and its influence on plasma kynurenine.

Detailed Description
-----------------
The study is a case-controlled observational trial. Forty 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 lung microbiota in patients treated with thyroid surgery. Secondly, it aims to evaluate microbiota and its influence on plasma kynurenine.

Official Title
-----------------
Characterisation of Gut Microbiota, Bispectral Index Data and Plasma Kynurenine in Patients Undergoing Thyroid Surgery

Conditions
-----------------
Sleep Deprivation

Intervention / Treatment
-----------------
* Drug: General anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ethnic Chinese; age, 18 to 65 years old; American Society of Anaesthesiologists (ASA) physical status I or II Exclusion Criteria: Cognitive difficulties Affiliated with the Social Security System Partial or complete gastrectomy Previous esophageal surgery Inability to conform to the study's requirements Deprivation of a right to decide by an administrative or juridical entity Ongoing participation or participation in another study <1 month ago

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group good sleepers<br>Duration of sleep was defined as the duration of all Bispectral Index data below 80 in the 12 hours of monitoring (from 18:00pm to 06:00am). Sleeping time are more than four hours. | Drug: General anesthesia<br>* 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.<br>|
| Group poor sleepers<br>Duration of sleep was defined as the duration of all Bispectral Index data below 80 in the 12 hours of monitoring (from 18:00pm to 06:00am). Sleeping time are less than four hours. | Drug: General anesthesia<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gut microbiota | this study will characterise the gut microbiota in 2 groups of 30 patients. | the first postoperative night | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bispectral index data | this study will characterise the Bispectral index data in 2 groups of 30 patients | the first postoperative night | 
| plasma kynurenine concentrations | this study will characterise the plasma kynurenine concentrations in 2 groups of 30 patients | baseline and the first postoperative night |