Status:
UNKNOWN
HbA1c and Neurocognitive Disorders
Lead Sponsor:
University of Thessaly
Collaborating Sponsors:
University Hospital, Ioannina
Larissa University Hospital
Conditions:
Neurocognitive Disorders
HbA1c
Eligibility:
All Genders
45-80 years
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 und...
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 prev...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2021
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT04736277
Start Date
December 1 2015
End Date
November 1 2021
Last Update
October 11 2021
Active Locations (1)
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1
University of Thessaly
Larissa, Greece, 41335