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

University of Thessaly

Status: Enrolling

Conditions: Postoperative Delirium

Treatments: Device: BIS

Study type: Interventional

Funder types: Other

Identifiers

NCT04736303

POD and BIS

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,400 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No 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)

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,400 participants in 2 patient groups

POD without BIS

No Intervention group

Description:

Assessing the incidence of POD in patients under general anethesia for elective non cardiac surgery, with CAM and Nu-DESC tools.

POD with BIS

Active Comparator group

Description:

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.

Treatment:

Device: BIS