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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postoperative Delirium

Intervention / Treatment
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* Device: BIS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients over 60 years of age an American Society of Anesthesiologists (ASA) physical status I to III undergoing elective non cardiac surgery under general anaesthesia native speakers of the Greek language eligible to leave the post-anaesthesia care unit an expected in-hospital stay at least 24 hours following surgery Exclusion Criteria: refused to participate or sign the informed consent form surgery or anaesthesia within the last 30 day any prior or current history involving an affliction of the central nervous system severe hearing or visual impairment psychiatric disorders a score less than 5 according the Geriatric Depression Scale (GDS-15) 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.) alcohol consumption less than 35 units/week drug dependence previous neuropsychological testing haemodynamical instability peri-procedural desaturation (one or more events of SpO2<80% for more than 2 minutes)

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: POD without BIS<br>Assessing the incidence of POD in patients under general anethesia for elective non cardiac surgery, with CAM and Nu-DESC tools. | |
| Active Comparator: POD with BIS<br>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. | Device: BIS<br>* The implementation of BIS monitoring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of POD | Assess the incidence of POD with CAM and Nu-DESC tools | 1st postoperative day |