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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04736303

Enrollment

1400

Registered

2021-02-03

Start date

2021-12-01

Completion date

2023-04-01

Last updated

2022-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Delirium

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

Interventions

DEVICEBIS

The implementation of BIS monitoring

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

Countries

Greece

Contacts

Primary ContactEleni Arnaoutoglou, MD, PhD

earnaout@gmail.com+306974301352

Backup ContactMaria Ntalouka, MD, PhD

maria.ntalouka@icloud.com+306973688099

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026