Patients ASA I, II, IIIPOCD ELANCT02841423
Postoperative Cognitive Dysfunction After Propofol Anesthesia for Noncardiac Surgery
A study testing neuropsychological test battery in people with Patients ASA I, II, III, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Background: Postoperative cognitive dysfunction (POCD) in elderly patients after noncardiac surgery is a common problem. Therefore,this study was designed to assess POCD after closed-loop coadministration of propofol and remifentanil guided by bispectral index in comparison to intravenous anesthesia in elderly… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Patients ASA I, II, III
- What is being tested?
- neuropsychological test battery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2013to Feb 2018
- Phase
- Interventional
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical status I-III;
- undergoing surgery (duration, > 1 h)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
E SAMAIN, PR contact
Lucie VETTORETTI contact
France1 site, 1 recruiting
- Recruiting
Chu Besancon
Besançon, 25000
E SAMAIN, PR, 0381668579
E SAMAIN, PR
About this study
Official title: Postoperative Cognitive Dysfunction After Intravenous Anesthesia or Closed-loop Coadministration of Propofol and Remifentanil Guided by Bispectral Index for Noncardiac Surgery : a Randomized Monocenter Study
Background: Postoperative cognitive dysfunction (POCD) in elderly patients after noncardiac surgery is a common problem.
Therefore,this study was designed to assess POCD after closed-loop coadministration of propofol and remifentanil guided by bispectral index in comparison to intravenous anesthesia in elderly patients undergoing major noncardiac surgery. Methods: After approval of the local ethical committee was obtained, 204 patients (American Society of Anesthesiologists physical status I-III; age, > 55 yr) undergoing surgery (duration, > 1 h) were enrolled into this pospective randomized monocenter study. Patients received anesthesia 3 days after using a neuropsychological test battery.
- Conditions
- Patients ASA I, II, III
- Being tested
- neuropsychological test battery
- Keywords
- physical status I-III;, age > 55 yr), undergoing surgery (duration, > 1 h)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuropsychological test batteryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| INTRAVENOUS ANESTHESIA | Experimental | neuropsychological test battery Receives: Procedure: neuropsychological test battery |
| CLOSED LOOP ANESTHESIA | Experimental | neuropsychological test battery Receives: Procedure: neuropsychological test battery |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of early POCD in elderly patients (aged 55 yrs or older)
Measured: 3 DAYS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startFeb 2013
- Primary completionAug 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients ASA I, II, IIIStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- E SAMAIN, PR, Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841423
- Sponsor's protocol ID
- API/2013/44
- Acronym
- POCD ELA
- Status last verified
- Aug 2016
- First submitted
- 20 Jul 2016
- Last updated
- 5 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Besch G, Vettoretti L, Claveau M, Boichut N, Mahr N, Bouhake Y, Liu N, Chazot T, Samain E, Pili-Floury S. Early post-operative cognitive dysfunction after closed-loop versus manual target controlled-infusion of propofol and remifentanil in patients undergoing elective major non-cardiac surgery: Protocol of the randomized controlled single-blind POCD-ELA trial. Medicine (Baltimore). 2018 Oct;97(40):e12558. doi: 10.1097/MD.0000000000012558.
PubMed 30290615
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Cognitive Dysfunction After Intravenous Anesthesia or Closed-loop Coadministration of Propofol and Remifentanil Guided by Bispectral Index for Noncardiac Surgery : a Randomized Monocenter Study
- ClinicalTrials.gov ID
- NCT02841423
- Acronym / sponsor ID
- POCD ELA / API/2013/44
- Conditions
- Patients ASA I, II, III
- Keywords
- physical status I-III;, age > 55 yr), undergoing surgery (duration, > 1 h)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 22 Jul 2016 (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.
Background: Postoperative cognitive dysfunction (POCD) in elderly patients after noncardiac surgery is a common problem.
Therefore,this study was designed to assess POCD after closed-loop coadministration of propofol and remifentanil guided by bispectral index in comparison to intravenous anesthesia in elderly patients undergoing major noncardiac surgery. Methods: After approval of the local ethical committee was obtained, 204 patients (American Society of Anesthesiologists physical status I-III; age, > 55 yr) undergoing surgery (duration, > 1 h) were enrolled into this pospective randomized monocenter study. Patients received anesthesia 3 days after using a neuropsychological test battery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INTRAVENOUS ANESTHESIA | Experimental | Procedure: neuropsychological test batteryneuropsychological test battery |
| CLOSED LOOP ANESTHESIA | Experimental | Procedure: neuropsychological test batteryneuropsychological test battery |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical status I-III;
- undergoing surgery (duration, > 1 h)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neuropsychological test battery | Procedure or surgery | CLOSED LOOP ANESTHESIA, INTRAVENOUS ANESTHESIA |
Primary outcome
the incidence of early POCD in elderly patients (aged 55 yrs or older)
Time frame: 3 DAYS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2016.
- Derived from this study: PubMed 30290615Besch G, Vettoretti L, Claveau M, Boichut N, Mahr N, Bouhake Y, Liu N, Chazot T, Samain E, Pili-Floury S. Early post-operative cognitive dysfunction after closed-loop versus manual target controlled-infusion of propofol and remifentanil in patients undergoing elective major non-cardiac surgery: Protocol of the randomized controlled single-blind POCD-ELA trial. Medicine (Baltimore). 2018 Oct;97(40):e12558. doi: 10.1097/MD.0000000000012558.
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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.
E SAMAIN, PR contact
Lucie VETTORETTI contact
E SAMAIN, PR principal investigator
Centre Hospitalier Universitaire de Besancon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neuropsychological test battery in people with Patients ASA I, II, III, 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 2 inclusion and 1 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 5 Aug 2016. 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?
Contact E SAMAIN, PR (03 81 66 85 79), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of early POCD in elderly patients (aged 55 yrs or older) (time frame: 3 DAYS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02841423, which also lists 1 linked publication.
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 5 Aug 2016.