Effect of General Anesthesia on Enterocyte Damage NCT02199275

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number	NCT02199275
Other study ID #	P/2013/174
Secondary ID
Status	Recruiting
Phase	N/A
First received	September 4, 2013
Last updated	July 23, 2014
Start date	August 2013
Est. completion date	August 2014

Study information
Verified date	July 2014
Source	Centre Hospitalier Universitaire de Besancon
Contact	n/a
Is FDA regulated	No
Health authority	France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type	Observational [Patient Registry]

Clinical Trial Summary

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.

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 ?

Recruitment information / eligibility
Status	Recruiting
Enrollment	50
Est. completion date	August 2014
Est. primary completion date	August 2014
Accepts healthy volunteers	No
Gender	Both
Age group	18 Years and older
Eligibility	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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country	Name	City	State
France	CHRU de Besançon	Besançon

Sponsors *(1)*
Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	I-FABP elevation after induction of general anesthesia	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	No

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Effect of General Anesthesia on Enterocyte Damage

Clinical Trial Details — Status: Recruiting

Administrative data

Study information

Clinical Trial Summary

Description:

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Locations

Sponsors (1)

Country where clinical trial is conducted

Outcome