Characterisation of Gut Microbiota, Bispectral Index Data and Plasma Kynurenine in Patients Undergoing Video-assisted Thoracic Surgery
NCT ID: NCT03985735
Last Updated: 2020-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
20 participants
OBSERVATIONAL
2019-08-01
2020-01-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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China Medical University, China
OTHER
Responsible Party
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Wen-fei Tan
Professor
Locations
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the First Hospital of China Medical University
Shenyang, Liaoning, China
Countries
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Other Identifiers
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20190609
Identifier Type: -
Identifier Source: org_study_id
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