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

August 17, 2022 updated by: Elena Arnaoutoglou, University of Thessaly

Assessing the Impact of the Implementation of BIS on the Incidence of Postoperative Delirium - A Monocentre Prospective Trial

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

The POD will be evaluated with the CAM and Nu-DESC tools, which have been adapted for the greek population.

Study Type

Interventional

Enrollment (Anticipated)

1400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Thessaly
      • Larissa, Thessaly, Greece, 41110
        • Recruiting
        • Univeristy of Thessaly
        • Contact:
        • Sub-Investigator:
          • Eleonora Stertsou, MD
        • Sub-Investigator:
          • Georgia Micha, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. refused to participate or sign the informed consent form
  2. surgery or anaesthesia within the last 30 day
  3. any prior or current history involving an affliction of the central nervous system
  4. severe hearing or visual impairment
  5. psychiatric disorders
  6. a score less than 5 according the Geriatric Depression Scale (GDS-15)
  7. 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.)
  8. alcohol consumption less than 35 units/week
  9. drug dependence
  10. previous neuropsychological testing
  11. haemodynamical instability
  12. peri-procedural desaturation (one or more events of SpO2<80% for more than 2 minutes)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: POD without BIS
Assessing the incidence of POD in patients under general anethesia for elective non cardiac surgery, with CAM and Nu-DESC tools.
ACTIVE_COMPARATOR: POD with BIS
Assessing the incidence of POD in patients under general anethesia for elective non cardiac surgery with the implementation of BIS monitoring, with CAM and Nu-DESC tools.
Device: BIS
The implementation of BIS monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of POD
Time Frame: 1st postoperative day
Assess the incidence of POD with CAM and Nu-DESC tools
1st postoperative day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Thessaly

Investigators

  • Principal Investigator: Maria Ntalouka, MD, PhD, University Hospital of Larissa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2021

Primary Completion (ANTICIPATED)

December 30, 2022

Study Completion (ANTICIPATED)

April 1, 2023

Study Registration Dates

First Submitted

October 2, 2020

First Submitted That Met QC Criteria

February 2, 2021

First Posted (ACTUAL)

February 3, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 19, 2022

Last Update Submitted That Met QC Criteria

August 17, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POD and BIS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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