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

NCT ID: NCT03137628

Last Updated: 2017-05-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-20
• Study Completion Date: 2017-05-15

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.

Conditions

Metabolomics

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

colectomy, GA and MV

Intervention Type: OTHER

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.

healthy controls

donated venous blood samples from healthy people undergoing physical examination but not general anesthesia or mechanical ventilation.

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lai Jiang, chief doctor

Role: STUDY_CHAIR

Xinhua Hospital affiliated to Medicine school,Shanghai Jiaotong University

Locations

Department of Anesthesia, Shanghai Xinhua hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

XH-17-005

Identifier Type: -

Identifier Source: org_study_id