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

China Medical University, China

Status: Completed

Conditions: Sleep Deprivation

Treatments: Drug: General anesthesia

Study type: Observational

Funder types: Other

Identifiers

NCT03981770

20190607

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

33 participants in 2 patient groups

Group good sleepers

Description:

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.

Treatment:

Drug: General anesthesia

Group poor sleepers

Description:

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.

Treatment:

Drug: General anesthesia