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Postoperative Cognitive Dysfunction After Propofol Anesthesia for Noncardiac Surgery (POCD ELA)

Primary Purpose

Patients ASA I, II, III

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

neuropsychological test battery

About this trial

This is an interventional diagnostic trial for Patients ASA I, II, III focused on measuring physical status I-III;, age > 55 yr), undergoing surgery (duration, > 1 h)

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

American Society of Anesthesiologists physical status I-III;
undergoing surgery (duration, > 1 h)

Exclusion Criteria:

Sites / Locations

Chu BesanconRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

INTRAVENOUS ANESTHESIA

CLOSED LOOP ANESTHESIA

Arm Description

neuropsychological test battery

Outcomes

Primary Outcome Measures

the incidence of early POCD in elderly patients (aged 55 yrs or older)

Secondary Outcome Measures

Full Information

NCT ID

NCT02841423

First Posted

July 20, 2016

Last Updated

August 4, 2016

Sponsor

Centre Hospitalier Universitaire de Besancon

1. Study Identification

Unique Protocol Identification Number

NCT02841423

Brief Title

Postoperative Cognitive Dysfunction After Propofol Anesthesia for Noncardiac Surgery

Acronym

POCD ELA

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Unknown status

Study Start Date

February 2013 (undefined)

Primary Completion Date

August 2017 (Anticipated)

Study Completion Date

February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Besancon

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patients ASA I, II, III

Keywords

physical status I-III;, age > 55 yr), undergoing surgery (duration, > 1 h)

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

INTRAVENOUS ANESTHESIA

Arm Type

Experimental

Arm Description

neuropsychological test battery

Arm Title

CLOSED LOOP ANESTHESIA

Arm Type

Experimental

Arm Description

neuropsychological test battery

Intervention Type

Procedure

Intervention Name(s)

neuropsychological test battery

Primary Outcome Measure Information:

Title

the incidence of early POCD in elderly patients (aged 55 yrs or older)

Time Frame

3 DAYS

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: American Society of Anesthesiologists physical status I-III; undergoing surgery (duration, > 1 h) Exclusion Criteria: -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

E SAMAIN, PR

Phone

03 81 66 85 79

First Name & Middle Initial & Last Name or Official Title & Degree

Lucie VETTORETTI

lvettoretti@chu-besancon.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

E SAMAIN, PR

Organizational Affiliation

Centre Hospitalier Universitaire de Besancon

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chu Besancon

City

Besancon

ZIP/Postal Code

25000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

E SAMAIN, PR

Phone

0381668579

First Name & Middle Initial & Last Name & Degree

E SAMAIN, PR

12. IPD Sharing Statement

Citations:

PubMed Identifier

30290615

Citation

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.

Results Reference

derived

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Postoperative Cognitive Dysfunction After Propofol Anesthesia for Noncardiac Surgery

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