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Effect of Different Anesthetics on the Change of Alarmins in Lung Cancer Patients Receiving Pulmonary Lobectomy

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sevoflurane
Propofol
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American society of Anesthesiology (ASA) status I-II
  • pathological diagnosis of lung cancer before surgery
  • receive pulmonary lobectomy
  • with normal lung function
  • without heart failure (NYHA>2), obstructive or restrictive lung disease
  • no history of other malignancy tumor
  • body mass index (Body mass, index, BMI) < 35kg/m2
  • no severe coagulopathy
  • no severe systemic or pulmonary infection
  • did not participate in other clinical trials

Exclusion Criteria:

  • persistent smoking history
  • immunosuppressive drug use 6 weeks before operation
  • receive total pneumonectomy
  • failure to complete treatment or follow-up
  • severe adverse drug reactions
  • severe postoperative complications

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    volatile anesthesia

    intravenous anesthesia

    Arm Description

    Use 2-3% sevoflurane to maintain the anesthesia during OLV surgery with bispectral index (BIS) 40-60.

    Anesthesia was maintained by a continuous infusion of propofol (4-6mg/kg/h)with BIS 40-60.

    Outcomes

    Primary Outcome Measures

    Change of level of HMGN1
    Change of level of HMGb1
    Change of level of sTLR4
    Change of level of IL-33
    Change of level of sST2

    Secondary Outcome Measures

    Disease-free survival
    disease-free survival means the amount of time that patient lives without known recurrence after surgery to the end of observation or recurrence.
    Overall survival
    Overall survival means the amount of time that patient lives to the end of observation or death.

    Full Information

    First Posted
    September 21, 2016
    Last Updated
    September 26, 2016
    Sponsor
    Tianjin Medical University Cancer Institute and Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02916147
    Brief Title
    Effect of Different Anesthetics on the Change of Alarmins in Lung Cancer Patients Receiving Pulmonary Lobectomy
    Official Title
    Comparison of Volatile and IV Anesthesia on the Change of Alarmins in Lung Cancer Patients Receiving Pulmonary Lobectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2016 (undefined)
    Primary Completion Date
    November 2018 (Anticipated)
    Study Completion Date
    January 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tianjin Medical University Cancer Institute and Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study aim to observe and compare the change of alarmins such as high mobility group nucleosome-binding protein-1 (HMGN1), high mobility group proteins b1 (HMGb1), Interleukin (IL)-33 and their soluble receptors including soluble toll like receptor 4 (sTLR4) and soluble ST2 (sST2) during pulmonary lobectomy for cancer patients receiving volatile anesthesia or intravenous anesthesia under one-lung ventilation (OLV). By which, this study will preliminarily evaluate the correlation of alarmins and prognosis as well as the effect of inhalational and intravenous anesthesia on the prognosis of surgical patients.
    Detailed Description
    During pulmonary lobectomy, as a result of OLV and surgical operation, patients can suffer from alveolar and systemic inflammatory response. Alarmin is endogenous peptide released by white blood cells and epithelial cells when the body undergo danger signal stimulation which can enhance immune response and has a double effect on tumor. Some alarmins and their soluble receptors such as HMGN1, HMGb1, IL-33 and their soluble receptors including sTLR4 and sST2 can be used as biomarkers for tumor progression. Previous studies have shown that sevoflurane anesthesia can reduce the level of inflammatory cytokines in bronchoalveolar lavage fluid. Meanwhile, the latest retrospective study indicated that the mortality of cancer patients receiving volatile anesthesia was significantly higher than that of intravenous anesthesia. At this stage, no study aimed to investigate the change of alarmins in broncho-alveoli and serum during OLV lung surgery and the possible effect of different anesthetics on them. Therefore, the investigators plan to enroll 40 patients with lung cancer receiving pulmonary lobectomy. Patients are randomly divided into sevoflurane volatile anesthesia group and propofol intravenous anesthesia group (n=20). Perioperative serum and bronchoalveolar lavage from ventilated lung are obtained, using ELISA method, to assay and compare the changes of alarmins such as HMGN1, HMGb1, IL-33 and their soluble receptors including sTLR4 and sST2 between two groups. All the patients will be followed up for 12 months. The correlation of alarmins and prognosis as well as the effect of volatile and intravenous anesthesia on the prognosis of patients will be preliminarily evaluated.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carcinoma, Non-Small-Cell Lung

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    volatile anesthesia
    Arm Type
    Experimental
    Arm Description
    Use 2-3% sevoflurane to maintain the anesthesia during OLV surgery with bispectral index (BIS) 40-60.
    Arm Title
    intravenous anesthesia
    Arm Type
    Active Comparator
    Arm Description
    Anesthesia was maintained by a continuous infusion of propofol (4-6mg/kg/h)with BIS 40-60.
    Intervention Type
    Drug
    Intervention Name(s)
    Sevoflurane
    Intervention Type
    Drug
    Intervention Name(s)
    Propofol
    Primary Outcome Measure Information:
    Title
    Change of level of HMGN1
    Time Frame
    10 min before OLV, 10 min after OLV, 1 day and 2 day after surgery
    Title
    Change of level of HMGb1
    Time Frame
    10 min before OLV, 10 min after OLV, 1 day and 2 day after surgery
    Title
    Change of level of sTLR4
    Time Frame
    10 min before OLV, 10 min after OLV, 1 day and 2 day after surgery
    Title
    Change of level of IL-33
    Time Frame
    10 min before OLV, 10 min after OLV, 1 day and 2 day after surgery
    Title
    Change of level of sST2
    Time Frame
    10 min before OLV, 10 min after OLV, 1 day and 2 day after surgery
    Secondary Outcome Measure Information:
    Title
    Disease-free survival
    Description
    disease-free survival means the amount of time that patient lives without known recurrence after surgery to the end of observation or recurrence.
    Time Frame
    12 months
    Title
    Overall survival
    Description
    Overall survival means the amount of time that patient lives to the end of observation or death.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: American society of Anesthesiology (ASA) status I-II pathological diagnosis of lung cancer before surgery receive pulmonary lobectomy with normal lung function without heart failure (NYHA>2), obstructive or restrictive lung disease no history of other malignancy tumor body mass index (Body mass, index, BMI) < 35kg/m2 no severe coagulopathy no severe systemic or pulmonary infection did not participate in other clinical trials Exclusion Criteria: persistent smoking history immunosuppressive drug use 6 weeks before operation receive total pneumonectomy failure to complete treatment or follow-up severe adverse drug reactions severe postoperative complications
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kaiyuan Wang, PhD
    Phone
    00862223340123
    Email
    93445729@qq.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kaiyuan Wang, PhD
    Organizational Affiliation
    Tianjin Medical University Cancer Institute and Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Effect of Different Anesthetics on the Change of Alarmins in Lung Cancer Patients Receiving Pulmonary Lobectomy

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