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

C

Centre Hospitalier Universitaire de Besancon

Status

Unknown

Conditions

Patients ASA I, II, III

Treatments

Procedure: neuropsychological test battery

Study type

Interventional

Funder types

Other

Identifiers

NCT02841423
API/2013/44

Details and patient eligibility

About

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.

Enrollment

204 estimated patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

204 participants in 2 patient groups

INTRAVENOUS ANESTHESIA
Experimental group
Description:
neuropsychological test battery
Treatment:
Procedure: neuropsychological test battery
CLOSED LOOP ANESTHESIA
Experimental group
Description:
neuropsychological test battery
Treatment:
Procedure: neuropsychological test battery

Trial contacts and locations

1

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Central trial contact

E SAMAIN, PR; Lucie VETTORETTI

Data sourced from clinicaltrials.gov

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