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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

Tracking Information
First Submitted Date June 7, 2019
First Posted Date June 14, 2019
Last Update Posted Date June 22, 2020
Actual Study Start Date August 1, 2019
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 19, 2020)
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
Original Primary Outcome Measures
 (submitted: June 8, 2019)
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
Change History
Current Secondary Outcome Measures
 (submitted: January 25, 2020)
  • Bispectral index data [ Time Frame: the first postoperative night ]
    this study will characterise the Bispectral index data in 2 groups of 30 patients
  • 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
Original Secondary Outcome Measures
 (submitted: June 8, 2019)
  • Bispectral index data [ Time Frame: the first postoperative night ]
    this study will characterise the Bispectral index data in 2 groups of 40 patients
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Characterisation of Gut Microbiota, Bispectral Index Data and Plasma Kynurenine in Patients Undergoing Video-assisted Thoracic Surgery
Official Title Characterisation of Gut Microbiota, Bispectral Index Data and Plasma Kynurenine in Patients Undergoing Video-assisted Thoracic Surgery
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.
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Lung Cancer
Intervention 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.
Study Groups/Cohorts
  • 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.

    Intervention: 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.

    Intervention: Drug: General anesthesia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 18, 2020)
20
Original Estimated Enrollment
 (submitted: June 8, 2019)
40
Actual Study Completion Date January 20, 2020
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: male
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03985735
Other Study ID Numbers 20190609
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Wen-fei Tan, China Medical University, China
Study Sponsor China Medical University, China
Collaborators Not Provided
Investigators Not Provided
PRS Account China Medical University, China
Verification Date June 2020