Effect of General Anesthesia on Enterocyte Damage (GUT)

July 23, 2014 updated by: Gael PITON, Centre Hospitalier Universitaire de Besancon

Impact of General Anesthesia on Enterocyte Damage

During non urgent surgery, general anesthesia might induce enterocyte damage. I-FABP is a performant biomarker of enterocyte damage. We aimed to study whether patient ongoing general anesthesia for non-urgent surgery have an elevation of plasma I-FABP concentration.

Study Overview

Status

Unknown

Conditions

Detailed Description

Inclusion criteria

  • Indication of non-urgent surgery
  • General anesthesia protocol using propofol and remifentanyl
  • One half of the patients have a history of ischemic arteriopathy
  • One half of the patients have no history of ischemic arteriopathy

Exclusion criteria

  • Age < 18 years old
  • Pregnant

Primary objective

Is there a significant elevation of I-FABP between the pre-anesthesic period and 11 minutes after induction of general anesthesia ?

Secondary objectives

  1. Is I-FABP elevation higher among patients with history of patent arteriopathy ?
  2. Is I-FABP elevation higher among patients presenting with hypotension during anesthesia ?

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25030
        • Recruiting
        • CHRU De Besancon
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults requiring non-urgent surgery, in whom a protocol of general anesthesia using propofol and remifentanyl with monitoring of bispectral index is expected.

Description

Inclusion criteria

  • Indication of non-urgent surgery
  • General anesthesia protocol using propofol and remifentanyl
  • One half of the patients have a history of ischemic arteriopathy
  • One half of the patients have no history of ischemic arteriopathy

Exclusion criteria

  • Age < 18 years old
  • Pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
I-FABP elevation after induction of general anesthesia
Time Frame: 11 minutes
Primary measure of plasma I-FABP before induction of general anesthesia. Second measure of plasma I-FABP concentration 11 minutes after induction of general anesthesia using a protocol of propofol and remifentanyl with monitoring of bispectral index.
11 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

August 1, 2014

Study Completion (Anticipated)

August 1, 2014

Study Registration Dates

First Submitted

September 4, 2013

First Submitted That Met QC Criteria

July 23, 2014

First Posted (Estimate)

July 24, 2014

Study Record Updates

Last Update Posted (Estimate)

July 24, 2014

Last Update Submitted That Met QC Criteria

July 23, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P/2013/174

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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