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

Completed

• Conditions: Sleep Deprivation
• Interventions: Drug: General anesthesia

• Registration Number: NCT03981770
• Lead Sponsor: China Medical University, China

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.

Study Timeline

• Study First Submitted: 2019-06-07
• Study First Submitted QC: 2019-06-08
• Study First Posted: 2019-06-11
• Study Start: 2019-09-01
• Primary Completion: 2019-12-31
• Status Verified: 2020-01
• Study Completion: 2020-01-17
• Last Update Submitted: 2020-01-25
• Last Update Posted: 2020-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 33

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

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 18:00pm to 06:00am). Sleeping time are more than four 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 18:00pm to 06:00am). Sleeping time are less than four hours.

Primary Outcome Measures

Name	Time	Method
gut microbiota	the first postoperative night	this study will characterise the gut microbiota in 2 groups of 30 patients.

Secondary Outcome Measures

Name	Time	Method
plasma kynurenine concentrations	baseline and the first postoperative night	this study will characterise the plasma kynurenine concentrations in 2 groups of 30 patients
Bispectral index data	the first postoperative night	this study will characterise the Bispectral index data in 2 groups of 30 patients

Trial Locations

Locations (1)

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