Status:

UNKNOWN

The Impact of the Implementation of BIS on the Incidence of Postoperative Delirium

Lead Sponsor:

University of Thessaly

Conditions:

Postoperative Delirium

Eligibility:

All Genders

60+ years

Phase:

NA

Brief Summary

This study will investigate the incidence of postoperative POD in patients undergoing non cardiac surgery under general anesthesia with and without the implementation of the BIS monitoring.T

Detailed Description

This study will compare the incidence of POD after elective non cardiac surgery conducted under general anesthesia before and after the implementation of BIS monitoring in our University Hospital. Th...

Eligibility Criteria

Inclusion

  • adult patients over 60 years of age
  • an American Society of Anesthesiologists (ASA) physical status I to III
  • undergoing elective non cardiac surgery under general anaesthesia
  • native speakers of the Greek language
  • eligible to leave the post-anaesthesia care unit
  • an expected in-hospital stay at least 24 hours following surgery

Exclusion

  • refused to participate or sign the informed consent form
  • surgery or anaesthesia within the last 30 day
  • any prior or current history involving an affliction of the central nervous system
  • severe hearing or visual impairment
  • psychiatric disorders
  • a score less than 5 according the Geriatric Depression Scale (GDS-15)
  • a score less than 4 for females and less than 2 for males according to the Lawton-Brody Instrumental Activities of Daily Living Scale (I.A.D.L.)
  • alcohol consumption less than 35 units/week
  • drug dependence
  • previous neuropsychological testing
  • haemodynamical instability
  • peri-procedural desaturation (one or more events of SpO2\<80% for more than 2 minutes)

Key Trial Info

Start Date :

December 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 1 2023

Estimated Enrollment :

1400 Patients enrolled

Trial Details

Trial ID

NCT04736303

Start Date

December 1 2021

End Date

April 1 2023

Last Update

August 19 2022

Active Locations (1)

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1

Univeristy of Thessaly

Larissa, Thessaly, Greece, 41110