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Status unknownNCT04736303Updated Aug 19, 2022

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

An interventional study of BIS in Postoperative Delirium, sponsored by University of Thessaly. Status unknown at 1 site in Greece. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2022-08-19.

Sponsored by University of Thessaly · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
1,400
Allocation
Non-randomized
Ages
60 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Postoperative Delirium

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03

In context

Emergence Delirium

788 studies on the registry are indexed under Emergence Delirium; 250 are open to participants now.

This study's planned enrollment of 1,400 is above the median of 120 across 491 interventional studies indexed under Emergence Delirium.

Browse Emergence Delirium studies →

Lead sponsor

University of Thessaly is the lead sponsor of 194 studies on the registry; 43 are open to participants now.

Browse University of Thessaly studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
1,400 participants (estimated)

Study arms

  • 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

Interventions

  • DeviceBIS

    The implementation of BIS monitoring

06

What researchers measure

Primary outcomes

  1. Incidence of POD

    Assess the incidence of POD with CAM and Nu-DESC tools

    Time frame: 1st postoperative day

07

Study locations

1 of 1 sites recruiting
  • Univeristy of Thessaly
    Larissa, Thessaly 41110, Greece
    • Eleni Arnaoutoglou, MD, PhD · Contact · earnaout@gmail.com · 2413501370
    • Maria Ntalouka, MD · Contact · maria.ntalouka@icloud.com · +306973688099
    • Maria Ntalouka, MD, PhD · Principal investigator
    • Eleni Arnaoutoglou, MD, PhD · Principal investigator
    • Metaxia Bareka, MD, PhD · Sub investigator
    • Konstantinos Stamoulis, MD, PhD · Sub investigator
    • Eleonora Stertsou, MD · Sub investigator
    • Georgia Micha, MD, PhD · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2021 (actual). Primary completion is estimated for Dec 2022, 12 months after the start.

Of 195 non-industry interventional studies with no phase under Emergence Delirium, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 39. This study's planned 12 months is below that.

Counting every sponsor, half of 196 studies reached it within 21 months; a quarter within 8 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 2, 2020
First posted
Feb 3, 2021
StartActual
Dec 1, 2021
Primary completionEst.
Dec 30, 2022
CompletionEst.
Apr 1, 2023
Last update
Aug 19, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04736303
Lead sponsor
University of Thessaly
Responsible party
Elena Arnaoutoglou (Professor of Anesthesiology, University of Thessaly) — Principal investigator
First posted
Feb 3, 2021
Start date
Dec 1, 2021
Primary completion
Dec 30, 2022 (estimated)
Completion
Apr 1, 2023 (estimated)
Last update
Aug 19, 2022

Study contacts

Eleni Arnaoutoglou, MD, PhD
Contact
earnaout@gmail.com
+306974301352
Maria Ntalouka, MD, PhD
Contact
maria.ntalouka@icloud.com
+306973688099
Eleni Arnaoutoglou, MD, PhD
study chair · University of Thessaly
Maria Ntalouka, MD, PhD
principal investigator · University Hospital of Larissa

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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