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NCT Number: NCT03985735

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

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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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

the First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

General anesthesia

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

China Medical University, China

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jun 14, 2019
Registry last updated
Jun 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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