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

Not Applicable

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: Sevoflurane; Drug: Propofol

• Registration Number: NCT02916147
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

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.

Study Timeline

• Status Verified: 2016-09
• Study First Submitted: 2016-09-21
• Study First Submitted QC: 2016-09-26
• Last Update Submitted: 2016-09-26
• Study First Posted: 2016-09-27
• Last Update Posted: 2016-09-27
• Study Start: 2016-10
• Primary Completion: 2018-11
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
volatile anesthesia	Sevoflurane	Use 2-3% sevoflurane to maintain the anesthesia during OLV surgery with bispectral index (BIS) 40-60.
intravenous anesthesia	Propofol	Anesthesia was maintained by a continuous infusion of propofol （4-6mg/kg/h）with BIS 40-60.

Primary Outcome Measures

Name	Time	Method
Change of level of HMGN1	10 min before OLV, 10 min after OLV, 1 day and 2 day after surgery
Change of level of HMGb1	10 min before OLV, 10 min after OLV, 1 day and 2 day after surgery
Change of level of sTLR4	10 min before OLV, 10 min after OLV, 1 day and 2 day after surgery
Change of level of IL-33	10 min before OLV, 10 min after OLV, 1 day and 2 day after surgery
Change of level of sST2	10 min before OLV, 10 min after OLV, 1 day and 2 day after surgery

Secondary Outcome Measures

Name	Time	Method
Disease-free survival	12 months	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	12 months	Overall survival means the amount of time that patient lives to the end of observation or death.