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Clinical Trials/NCT02841423
NCT02841423
Unknown
Not Applicable

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

Centre Hospitalier Universitaire de Besancon1 site in 1 country204 target enrollmentFebruary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patients ASA I, II, III
Sponsor
Centre Hospitalier Universitaire de Besancon
Enrollment
204
Locations
1
Primary Endpoint
the incidence of early POCD in elderly patients (aged 55 yrs or older)
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
February 2018
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: 3 DAYS

Study Sites (1)

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