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
About this trial
This is an interventional basic science trial for Carcinoma, Non-Small-Cell Lung
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
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
NCT ID
NCT02916147
First Posted
September 21, 2016
Last Updated
September 26, 2016
Sponsor
Tianjin Medical University Cancer Institute and Hospital
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
Learn more about this trial
Effect of Different Anesthetics on the Change of Alarmins in Lung Cancer Patients Receiving Pulmonary Lobectomy
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