Postoperative Cognitive Dysfunction After Propofol Anesthesia for Noncardiac Surgery
POCD ELA
1 other identifier
interventional
204
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 20, 2016
CompletedFirst Posted
Study publicly available on registry
July 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedAugust 5, 2016
August 1, 2016
4.5 years
July 20, 2016
August 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the incidence of early POCD in elderly patients (aged 55 yrs or older)
3 DAYS
Study Arms (2)
INTRAVENOUS ANESTHESIA
EXPERIMENTALneuropsychological test battery
CLOSED LOOP ANESTHESIA
EXPERIMENTALneuropsychological test battery
Interventions
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologists physical status I-III;
- undergoing surgery (duration, \> 1 h)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chu Besancon
Besançon, 25000, France
Related Publications (1)
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.
PMID: 30290615DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
E SAMAIN, PR
Centre Hospitalier Universitaire de Besancon
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2016
First Posted
July 22, 2016
Study Start
February 1, 2013
Primary Completion
August 1, 2017
Study Completion
February 1, 2018
Last Updated
August 5, 2016
Record last verified: 2016-08