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

Sleep Deprivation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03981770
• Other study ID #: 20190607
• Status: Completed
• Start date: September 1, 2019
• Est. completion date: January 17, 2020

Study information

• Verified date: January 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: January 17, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep Deprivation

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.

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