HbA1c and Neurocognitive Disorders

Study Overview
=================
Brief Summary
-----------------
Preliminary evidence suggest a possible relationship between HbA1c and perioperative neurocognitive disorders (NCD). We are going to investigate whether the preoperative value of HbA1c in patients undergoing elective non-cardiac surgery under general anesthesia, are related with increased risk of perioperative NCD.

Detailed Description
-----------------
It is estimated that approximately 10% of elderly undergoing surgery will develop cognitive changes perioperatively, while in some reports the incidence rises up to 80%. Despite the reported high prevalence of perioperative neurocognitive disorders (NCD), their exact etiology is still largely unknown. Preliminary evidence suggest a possible relationship between HbA1c and perioperative neurocognitive disorders (NCD). We are going to investigate whether the preoperative value of HbA1c in patients undergoing elective non-cardiac surgery under general anesthesia, are related with increased risk of perioperative NCD.

Official Title
-----------------
The Effect of HbA1c on Perioperative Neurocognitive Disorders in Patients Undergoing Elective Non-cardiac Surgery Under General Anesthesia.

Conditions
-----------------
Neurocognitive Disorders, HbA1c

Intervention / Treatment
-----------------
* Other: Preoperative HbA1c


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) 45 - 80 years 2) American Society of Anesthesiologists physical status I to III 3) elective general, urological, gynecological and orthopedic surgery under general anesthesia 4) native speakers of the Greek language Exclusion Criteria: 1) refused to participate or sign the informed consent form 2) had undergone surgery or anesthesia within the last 30 days 3) had any prior or current history involving an affliction of the central nervous system 4) were diagnosed with severe cognitive decline based on the 16 - item Informant Questionnaire on Cognitive Decline (IQCODE - 16) 5) suffered from severe hearing or visual impairment 6) any psychiatric disorder 7) had a score >5 in the Geriatric Depression Scale (GDS - 15) 8) or a score in females < 4 males < 2 in the Lawton - Brody Instrumental Activities of Daily Living Scale (I.A.D.L.) 9) reported alcohol consumption > 35 units/week 10) drug dependence 11) had undergone previous neuropsychological testing 12) Diabetes Mellitus type II with > 10 years of diagnosis 13) Diabetes Mellitus type I 14) Hemoglobin A1c (HbA1c) > 7.5% 15) suffered from hemodynamical instability (> 20% alterations of blood pressure perioperatively) 16) or desaturation (one or more events of SpO2 < 80% for more than 2 minutes) peri-operatively 17) or blood loss of more than one unit

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Noncardiac surgery<br>Documentation of HbA1c in patients undergoing noncardiac surgery under general anesthesia | Other: Preoperative HbA1c<br>* Documentation of the preopetative HbA1c in patients undergoing noncardiac surgery under general anesthesia<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Postoperative Neurocognitive Disorders assessed with CAM | Screening for POD assessed with CAM | 1st postoperative day | 
| Incidence of Postoperative Neurocognitive Disorders with IQCODE-16 | Screening for POCD with IQCODE-16 | 10th postoperative day | 
| Incidence of Postoperative Neurocognitive Disorders with IQCODE-16 | Screening for POCD with IQCODE-16 | 3 months postoperatively | 
| Incidence of Postoperative Neurocognitive Disorders with IQCODE-16 | Screening for POCD with IQCODE-16 | 6 months postoperatively | 
| Incidence of Postoperative Neurocognitive Disorders with IQCODE-16 | Screening for POCD with IQCODE-16 | 9 months postoperatively |