The Impact of the Implementation of BIS on the Incidence of Postoperative Delirium
NCT ID: NCT04736303
Last Updated: 2022-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1400 participants
INTERVENTIONAL
2021-12-01
2023-04-01
Brief Summary
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Detailed Description
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The POD will be evaluated with the CAM and Nu-DESC tools, which have been adapted for the greek population.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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POD without BIS
Assessing the incidence of POD in patients under general anethesia for elective non cardiac surgery, with CAM and Nu-DESC tools.
No interventions assigned to this group
POD with 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.
BIS
The implementation of BIS monitoring
Interventions
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BIS
The implementation of BIS monitoring
Eligibility Criteria
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Inclusion Criteria
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
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)
60 Years
ALL
No
Sponsors
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University of Thessaly
OTHER
Responsible Party
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Elena Arnaoutoglou
Professor of Anesthesiology
Principal Investigators
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Eleni Arnaoutoglou, MD, PhD
Role: STUDY_CHAIR
University of Thessaly
Maria Ntalouka, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Larissa
Locations
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Univeristy of Thessaly
Larissa, Thessaly, Greece
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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POD and BIS
Identifier Type: -
Identifier Source: org_study_id
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