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

NCT ID: NCT02916147

Last Updated: 2016-09-27

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2019-01-31

Brief Summary

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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

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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.

Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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volatile anesthesia

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

Group Type EXPERIMENTAL

Sevoflurane

Intervention Type DRUG

intravenous anesthesia

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

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Interventions

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Sevoflurane

Intervention Type DRUG

Propofol

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kaiyuan Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Cancer Institute and Hospital

Central Contacts

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Kaiyuan Wang, PhD

Role: CONTACT

00862223340123

Other Identifiers

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E2016066

Identifier Type: -

Identifier Source: org_study_id

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