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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03981770
Other study ID # 20190607
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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