Sleep DeprivationNCT03981770
Characterisation of Gut Microbiota, Bispectral Index Data and Plasma Kynurenine in Patients Undergoing Thyroid Surgery
An observational study of Sleep Deprivation, run by China Medical University, China at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Sleep Deprivation
- What is being tested?
- General anesthesia
- Type of treatment
- Injection or infusion
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 17 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ethnic Chinese;
- age, 18 to 65 years old;
- American Society of Anaesthesiologists (ASA) physical status I or II
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
the First Hospital of China Medical University
Shenyang, Liaoning, 110001
About this study
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.
Read the 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.
- Conditions
- Sleep Deprivation
- Being tested
- General anesthesia
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anesthesiaDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: General anesthesia | |
| 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. Receives: Drug: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
gut microbiota
this study will characterise the gut microbiota in 2 groups of 30 patients.
Measured: the first postoperative night
Secondary outcomes (2)
Bispectral index data
this study will characterise the Bispectral index data in 2 groups of 30 patients
Measured: the first postoperative night
plasma kynurenine concentrations
this study will characterise the plasma kynurenine concentrations in 2 groups of 30 patients
Measured: baseline and the first postoperative night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start1 Sep 2019
- Primary completion31 Dec 2019
- Study completion17 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-fei Tan, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981770
- Sponsor's protocol ID
- 20190607
- Status last verified
- Jan 2020
- First submitted
- 7 Jun 2019
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of Gut Microbiota, Bispectral Index Data and Plasma Kynurenine in Patients Undergoing Thyroid Surgery
- ClinicalTrials.gov ID
- NCT03981770
- Acronym / sponsor ID
- 20190607
- Conditions
- Sleep Deprivation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 17 Jan 2020 (actual)
- First posted
- 11 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group good sleepers | – | Drug: General anesthesiaDuration 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 | – | Drug: General anesthesiaDuration 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- ethnic Chinese;
- age, 18 to 65 years old;
- American Society of Anaesthesiologists (ASA) physical status I or II
Key exclusion criteria (7 listed)
- Cognitive difficulties
- Affiliated with the Social Security System
- Partial or complete gastrectomy
- Previous esophageal surgery
- Inability to conform to the study's requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General anesthesiaFor 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. | Drug | Group good sleepers, Group poor sleepers |
Primary outcome
gut microbiota
Time frame: the first postoperative night
this study will characterise the gut microbiota in 2 groups of 30 patients.
2 secondary outcomes
Bispectral index data
Time frame: the first postoperative night
plasma kynurenine concentrations
Time frame: baseline and the first postoperative night
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Deprivation, run by China Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gut microbiota (time frame: the first postoperative night). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.