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

Not Applicable

• Conditions: Postoperative Delirium
• Interventions: Device: BIS

• Registration Number: NCT04736303
• Lead Sponsor: University of Thessaly

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.

Study Timeline

• Study First Submitted: 2020-10-02
• Study First Submitted QC: 2021-02-02
• Study First Posted: 2021-02-03
• Study Start: 2021-12-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-17
• Last Update Posted: 2022-08-19
• Primary Completion: 2022-12-30
• Study Completion: 2023-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
POD with BIS	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.

Primary Outcome Measures

Name	Time	Method
Incidence of POD	1st postoperative day	Assess the incidence of POD with CAM and Nu-DESC tools

Trial Locations

Locations (1)

Univeristy of Thessaly; 🇬🇷 Larissa, Thessaly, Greece