Postoperative Cognitive Dysfunction After Propofol Anesthesia for Noncardiac Surgery

NCT ID: NCT02841423

Last Updated: 2016-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2018-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Patients ASA I, II, III

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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INTRAVENOUS ANESTHESIA

neuropsychological test battery

Group Type EXPERIMENTAL

neuropsychological test battery

Intervention Type PROCEDURE

CLOSED LOOP ANESTHESIA

neuropsychological test battery

Group Type EXPERIMENTAL

neuropsychological test battery

Intervention Type PROCEDURE

Interventions

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neuropsychological test battery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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E SAMAIN, PR

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Besancon

Locations

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Chu Besancon

Besançon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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E SAMAIN, PR

Role: CONTACT

03 81 66 85 79

Lucie VETTORETTI

Role: CONTACT

Facility Contacts

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E SAMAIN, PR

Role: primary

0381668579

References

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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.

Reference Type DERIVED
PMID: 30290615 (View on PubMed)

Other Identifiers

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API/2013/44

Identifier Type: -

Identifier Source: org_study_id

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