Effect of General Anesthesia on Enterocyte Damage | NCT02199275

Studies
Effect of General Anesthesia on Enterocyte Damage

NCT02199275

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Unknown status

Last Update Posted

Jul 24, 2014Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Non-urgent Surgery
General Anesthesia

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Aug 2014Estimated

Completion Date

Aug 2014Estimated

First Submitted Date

Sep 4, 2013

First Submission Date that Met QC Criteria

Jul 23, 2014

First Posted Date

Jul 24, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2014

Last Update Posted Date

Jul 24, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gael PITON, MCU-PH, Centre Hospitalier Universitaire de BesanconPrincipal Investigator

Lead Sponsor

Centre Hospitalier Universitaire de BesanconOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU de Besançon	Recruiting	Besançon		25030	France