NCT02916147

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

2.1 years

First QC Date

September 21, 2016

Last Update Submit

September 26, 2016

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (2)

  • Disease-free survival

    12 months

  • Overall survival

    12 months

Study Arms (2)

volatile anesthesia

EXPERIMENTAL

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

Drug: Sevoflurane

intravenous anesthesia

ACTIVE COMPARATOR

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

Drug: Propofol

Interventions

SevofluraneDRUG
volatile anesthesia
PropofolDRUG
intravenous anesthesia

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

SevofluranePropofol

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Kaiyuan Wang, PhD

    Tianjin Medical University Cancer Institute and Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaiyuan Wang, PhD

CONTACT

0086222334012393445729@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2016

First Posted

September 27, 2016

Study Start

October 1, 2016

Primary Completion

November 1, 2018

Study Completion

January 1, 2019

Last Updated

September 27, 2016

Record last verified: 2016-09