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

Postoperative Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04736303
• Other study ID #: POD and BIS
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: April 1, 2023

Study information

• Verified date: August 2022
• Source: University of Thessaly
• Contact: Eleni Arnaoutoglou, MD, PhD
• Phone: +306974301352
• Email: earnaout[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: April 1, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Delirium
• Postoperative Delirium

Intervention

Device:
• BIS
The implementation of BIS monitoring

Locations

Country	Name	City	State
Greece	Univeristy of Thessaly	Larissa	Thessaly

Sponsors (1)

Lead Sponsor	Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

Outcome

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