Non-urgent SurgeryGUTNCT02199275
Effect of General Anesthesia on Enterocyte Damage
An observational study of Non-urgent Surgery and General Anesthesia, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-urgent Surgery, General Anesthesia
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2013to Aug 2014
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- 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
Who cannot join
- Age < 18 years old
- Pregnant
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU de Besançon
Besançon, 25030
Gaël Piton, MD, 0033381668127, gpiton@chu-besancon.fr
About this study
Official title: 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.
Read the 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 ?
- Conditions
- Non-urgent Surgery, General Anesthesia
- Keywords
- Non-urgent surgery, General anesthesia, Enterocyte damage, Intestinal fatty acid-binding protein
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 11 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startAug 2013
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-urgent SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gael PITON, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02199275
- Sponsor's protocol ID
- P/2013/174
- Acronym
- GUT
- Status last verified
- Jul 2014
- First submitted
- 4 Sep 2013
- Last updated
- 24 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of General Anesthesia on Enterocyte Damage
- ClinicalTrials.gov ID
- NCT02199275
- Acronym / sponsor ID
- GUT / P/2013/174
- Conditions
- Non-urgent Surgery, General Anesthesia
- Keywords
- Non-urgent surgery, General anesthesia, Enterocyte damage, Intestinal fatty acid-binding protein
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 24 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 ?
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Age < 18 years old
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-urgent Surgery and General Anesthesia, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
I-FABP elevation after induction of general anesthesia (time frame: 11 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2014.