Characterisation of Gut Microbiota, Bispectral Index Data and Plasma Kynurenine in Patients Undergoing Thyroid Surgery
January 25, 2020 updated by: Wen-fei Tan, China Medical University, China
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 Overview
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 Type
Observational
Enrollment (Actual)
33
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Liaoning
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Shenyang, Liaoning, China, 110001
- The First Hospital of China Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
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
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group good sleepers
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.
|
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.
|
|
Group poor sleepers
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
gut microbiota
Time Frame: the first postoperative night
|
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
Time Frame: the first postoperative night
|
this study will characterise the Bispectral index data in 2 groups of 30 patients
|
the first postoperative night
|
|
plasma kynurenine concentrations
Time Frame: baseline and the first postoperative night
|
this study will characterise the plasma kynurenine concentrations in 2 groups of 30 patients
|
baseline and the first postoperative night
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2019
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
January 17, 2020
Study Registration Dates
First Submitted
June 7, 2019
First Submitted That Met QC Criteria
June 8, 2019
First Posted (Actual)
June 11, 2019
Study Record Updates
Last Update Posted (Actual)
January 28, 2020
Last Update Submitted That Met QC Criteria
January 25, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20190607
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.