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

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ClinicalTrials.gov Identifier: NCT03985735
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Wen-fei Tan, China Medical University, China

Brief 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 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. 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 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
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Characterisation of Lung Microbiota, Bispectral Index Data and Plasma Kynurenine in Patients Undergoing Video-assisted Thoracic Surgery
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : February 28, 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 18:00pm to 06:00am).

Sleeping time are more than four 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 18:00pm to 06:00am).

Sleeping time are less than four 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 microbiota [ Time Frame: just before leaving the post-anesthesia care unite ]
    this study will characterise the lung microbiota in 2 groups of 20 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 40 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 40 patients



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 1. ethnic Chinese;
  • 2. age, 18 to 65 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
  • Deprivation of a right to decide by an administrative or juridical entity
  • Ongoing participation or participation in another study <1 month ago

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


Contacts
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Contact: Wenfei Tan, PhD 024-83283100 winfieldtan@hotmail.com

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     History of Changes
Other Study ID Numbers: 20190609
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019

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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