HbA1c and Neurocognitive Disorders

University of Thessaly

Status: Unknown

Conditions: HbA1c; Neurocognitive Disorders

Treatments: Other: Preoperative HbA1c

Study type: Observational

Funder types: Other

Identifiers

NCT04736277

HbA1c and NCD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 288 estimated patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

288 participants in 1 patient group

Noncardiac surgery

Description:

Documentation of HbA1c in patients undergoing noncardiac surgery under general anesthesia

Treatment:

Other: Preoperative HbA1c