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Effect of General Anesthesia and Mechanical Ventilation on Plasma Metabolite in Patient With Colorectal Cancer Resection

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ClinicalTrials.gov Identifier: NCT03137628
Recruitment Status : Unknown
Verified April 2017 by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Active, not recruiting
First Posted : May 3, 2017
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Tracking Information
First Submitted Date April 24, 2017
First Posted Date May 3, 2017
Last Update Posted Date May 3, 2017
Actual Study Start Date March 20, 2017
Estimated Primary Completion Date May 5, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 28, 2017)
metabolomics [ Time Frame: Outcome measure will be assessed right after all samples are collected, which is expected to on May 5, 2017, and MHD files containing compound IDs, m/z values and so on will be reported about 10 days later. ]
Thaw Frozen plasma, add methanol and shake. Isolate supernatant after centrifugation. Employ Globle LC-Q-TOF-MS profiling to analyze metabolites of plasma via an Agilent-1200 LC system, coupled with an electrospray Ionization source and an Agilent-6520 Q-TOF mass spectrometry. Utilize Agilent's Mass Hunter Qualitative Analysis Software to process the MS spectra for peak detection, and generate a list detected peak intensities with the retention time-m/z data pairs as identiers. Process integrated raw RHPLC-Q-TOF-MS data with Agilent Mass Hunter Qualitative Analysis and Mass Profiler software. Optimize and choose parameters as follows: the range of m/z values from 80 to 100, and peak filters set to centroid height with > 100 counts, and compound filters set the base peak to > 1000 counts. MHD files will be create, containing compound IDs, and further processing will be performed with Mass Profiler software, which aligns mass features across multiple LC-MS data files.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effect of General Anesthesia and Mechanical Ventilation on Plasma Metabolite in Patient With Colorectal Cancer Resection
Official Title Study on the Effect of Conventional General Anesthesia and Mechanical Ventilation on Plasma Small Molecule Metabolites in Patients With Colorectal Cancer Resection
Brief Summary

As a newly developed subject, metabolomics can detect accurately and quantitatively small molecule metabolites such as proteins, carbohydrates and lipids from plasma, tissue and even single cell, which aims to analyze systemic dynamic change during physiological and pathological processes, and thus reveals certain reactions that whole organism responds to specific stimulation.

Colorectal cancer is one of common gastrointestinal tumors, whose morbidity rate tends to increase in recent years for modern diet and life style, and colectomy serves as one standard treatment for it. Under total stimulation of surgical operation, general anesthesia and mechanical ventilation, a series of stress reactions happen complicatedly to colorectal patients during anesthesia-ventilation process. Without timely recognition and management of adverse reactions, side effects like hypoxemia, hemorrhage, inflammation, and even death will happen intraoperatively or postoperatively.

With different metabolomics methods applied to collect, detect and analyze blood samples, metabolomics provides an innovatory approach to elucidate systemic response during anesthesia-colectomy process with multi-factors included. By analyzing and comparing dramatic alteration of small molecule metabolites in colorectal cancer patients' or healthy controls' plasma in this project, data can reflect the influence of certain disease (colorectal cancer), anesthetics and mechanical ventilation on colorectal patients with colectomy, which is helpful for prevention and treatment of intraoperative and postoperative complications.

Detailed Description

Nowadays, more and more attention are paid to system biology and its relative techniques, such as gene sequencing,nuclear magnetic resonance, mass spectrometry and so on. As a newly developed subject, metabolomics can detect accurately and quantitatively small molecule metabolites such as proteins, carbohydrates and lipids from plasma, tissue and even single cell, which aims to analyze systemic dynamic change during physiological and pathological processes, and thus reveals certain reactions that whole organism responds to specific stimulation.

Colorectal cancer is one of common gastrointestinal tumors, whose morbidity rate tends to increase in recent years for modern diet and life style, and colectomy serves as one standard treatment for it. Under total stimulation of surgical operation, general anesthesia and mechanical ventilation, a series of stress reactions happen complicatedly to colorectal patients during anesthesia-ventilation process. Without timely recognition and management of adverse reactions, side effects like hypoxemia, hemorrhage, inflammation, and even death will happen intraoperatively or postoperatively.

With different metabolomics methods applied to collect, detect and analyze blood samples, metabolomics provides an innovatory approach to elucidate systemic response during anesthesia-colectomy process with multi-factors included. By analyzing and comparing dramatic alteration of small molecule metabolites in colorectal cancer patients' or healthy controls' plasma in this project, data can reflect the influence of certain disease (colorectal cancer), anesthetics and mechanical ventilation on colorectal patients with colectomy, which is helpful for prevention and treatment of intraoperative and postoperative complications.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
plasma seperated from venous blood via centrifugation
Sampling Method Non-Probability Sample
Study Population colorectal cancer patients and healthy controls
Condition Metabolomics
Intervention Other: colectomy, GA and MV

general anesthesia protocol: anesthesia induction (midazolam 0.1mg/kg, sufentanil 0.5ug/kg, etomidate 0.3mg/kg, cisatracurium 0.2mg/kg); anesthesia maintenance [sevoflurane 1.5-3%, cisatracurium 0.1mg/kg/h, sufentanil is supplemented during the entire surgical procedure according to patients' anesthetic situation, dexmedetomidine(used conditionally)0.4ug/kg/h].

mechanical ventilation protocol: tidal volume 6-8 ml/kg, positive end-expiratory pressure 5 cmH2O, oxygen concentration 40%; respiratory rate 10-15/min, inspiratory/expiratory ratio 1:1.5.

Study Groups/Cohorts
  • patients undergoing colectomy, GA and MV
    venous blood samples collected from colorectal cancer patients undergoing selective colectomy with general anesthesia(GA) and mechanical ventilation(MV) before general anethesia and the third hour after
    Intervention: Other: colectomy, GA and MV
  • healthy controls
    donated venous blood samples from healthy people undergoing physical examination but not general anesthesia or mechanical ventilation.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 28, 2017)
80
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 15, 2017
Estimated Primary Completion Date May 5, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Colorectal cancer patients inclusion criteria: undergo elective colectomy with general anesthesia and mechanical ventilation lasting for > 3.5 hours; classified as physical status I to III according to the American Society of Anesthesiologists Physical Status Classification System; Written informed consent is approved.
  • Healthy controls inclusion criteria: volunteers with regular physical examination in nearly three years;without chronic disease; without recent infection in three months; Written informed consent is approved.

Exclusion Criteria:

  • Distant metastases; hemodilution with massive fluid supply; recent anaesthetics or mechanical ventilation treatment;children;women during pregnancy or lactation; being involved in other clinical subjects.
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 55 Years   (Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03137628
Other Study ID Numbers XH-17-005
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study Sponsor Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators Not Provided
Investigators
Study Chair: Lai Jiang, chief doctor Xinhua Hospital affiliated to Medicine school,Shanghai Jiaotong University
PRS Account Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Verification Date April 2017