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

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ClinicalTrials.gov Identifier: NCT03985735
Recruitment Status : Completed
First Posted : June 14, 2019
Last Update Posted : June 22, 2020
Sponsor:
Information provided by (Responsible Party):
Wen-fei Tan, China Medical University, China

Brief 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. Secondly, it aims to evaluate microbiota and its influence on plasma kynurenine.

Condition or disease Intervention/treatment
Lung Cancer Drug: General anesthesia

Detailed Description:
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. Secondly, it aims to evaluate microbiota and its influence on plasma kynurenine.

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Characterisation of Gut Microbiota, Bispectral Index Data and Plasma Kynurenine in Patients Undergoing Video-assisted Thoracic Surgery
Actual Study Start Date : August 1, 2019
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : January 20, 2020

Resource links provided by the National Library of Medicine


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 20:00pm to 06:00am).

Sleeping time are more than six hours.

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. 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.

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.

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. 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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Bispectral index data [ Time Frame: the first postoperative night ]
    this study will characterise the Bispectral index data in 2 groups of 30 patients

  2. 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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 .

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985735


Locations
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China, Liaoning
the First Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Sponsors and Collaborators
China Medical University, China
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Responsible Party: Wen-fei Tan, Professor, China Medical University, China
ClinicalTrials.gov Identifier: NCT03985735    
Other Study ID Numbers: 20190609
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 22, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs