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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04736303
Other study ID # POD and BIS
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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