Characterisation of Gut Microbiota, Bispectral Index Data and Plasma Kynurenine in Patients Undergoing Video-assisted Thoracic Surgery

An observational study of Lung Cancer, run by China Medical University, China at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The study is a case-controlled observational trial. Sixty 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 gut and lung microbiota in patients with lung cancer treated with surgery. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Lung Cancer
What is being tested?: General anesthesia
Type of treatment: Injection or infusion
How many people: 20 participants
Where: 1 siteChina
Study dates: 1 Aug 2019to 20 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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: The study is a case-controlled observational trial. Sixty patients will be divided into 2 groups (good or poor sleepers) depending on their first postoperative night Bispectral index data.

Who may be able to join

1. ethnic Chinese;
2. age, 18 to 75 years old;
3. American Society of Anaesthesiologists (ASA) physical status I or II;
4. required VATS for lung surgery and one lung ventilation .

Who cannot join

Cognitive difficulties
Partial or complete gastrectomy
Previous esophageal surgery
Previous treated by radiotherapy or surgery
Inability to conform to the study's requirements
body mass index exceeding 30 kg/m2

Show all 10Show fewer

Deprivation of a right to decide by an administrative or juridical entity
Ongoing participation or participation in another study <1 month ago
preoperative Pittsburgh Sleep Quality Index global scores higher than 6
recent (< 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics, hormonal medication, laxatives, proton pump inhibitors, insulin sensitizers or traditional Chinese medicine

Trial locations and contacts

1 site in 1 country.

China1 site

the First Hospital of China Medical University
Shenyang, Liaoning, 110001

Other trials in China

About this study

Read the detailed description

Conditions: Lung Cancer
Being tested: General anesthesia
Medical subject headings: Lung Neoplasms

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. Additional cisatracurium （0.05 mg/kg）and fentanyl (30-50 μg at the end of surgery) were used as needed, in accordance with the clinical requirements.

Study groups in NCT03985735
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 20:00pm to 06:00am). Sleeping time are more than six 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 20:00pm to 06:00am). Sleeping time are less than two hours. Receives: Drug: General anesthesia

What is being measured

The primary outcome is the main question the study is designed to answer.

lung and gut microbiota
this study will characterise the lung and gut microbiota in 2 groups of 30 patients
Measured: from baseline to postoperative 72 hours

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.

1 Aug 201920 Jan 2020

First posted14 Jun 2019
Study start1 Aug 2019
Primary completion31 Dec 2019
Study completion20 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Lung CancerStudies 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: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03985735
Sponsor's protocol ID: 20190609
Status last verified: Jun 2020
First submitted: 7 Jun 2019
Last updated: 22 Jun 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 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 Video-assisted Thoracic Surgery
ClinicalTrials.gov ID: NCT03985735
Acronym / sponsor ID: 20190609
Conditions: Lung Cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: China Medical University, ChinaUniversity, hospital or other
Study start: 1 Aug 2019 (actual)
Primary completion: 31 Dec 2019 (actual)
Study completion: 20 Jan 2020 (actual)
First posted: 14 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.

Detailed description

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 20:00pm to 06:00am). Sleeping time are more than six 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 20:00pm to 06:00am). Sleeping time are less than two hours.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The study is a case-controlled observational trial. Sixty patients will be divided into 2 groups (good or poor sleepers) depending on their first postoperative night Bispectral index data.

Key inclusion criteria (4 listed)

1. ethnic Chinese;
2. age, 18 to 75 years old;
3. American Society of Anaesthesiologists (ASA) physical status I or II;
4. required VATS for lung surgery and one lung ventilation .

Key exclusion criteria (10 listed)

Cognitive difficulties
Partial or complete gastrectomy
Previous esophageal surgery
Previous treated by radiotherapy or 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. Additional cisatracurium （0.05 mg/kg）and fentanyl (30-50 μg at the end of surgery) were used as needed, in accordance with the clinical requirements.	Drug	Group good sleepers, Group poor sleepers

Primary outcome

lung and gut microbiota
Time frame: from baseline to postoperative 72 hours
this study will characterise the lung and 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 22 Jun 2020.

Related trials for Lung Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
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Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer

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 Lung Cancer, 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 4 inclusion and 10 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 22 Jun 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?

lung and gut microbiota (time frame: from baseline to postoperative 72 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03985735.

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 22 Jun 2020.