HbA1c and Neurocognitive Disorders

• Conditions: Neurocognitive Disorders; HbA1c
• Interventions: Other: Preoperative HbA1c

• Registration Number: NCT04736277
• Lead Sponsor: University of Thessaly

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.

Study Timeline

• Study Start: 2015-12-01
• Study First Submitted: 2020-10-24
• Study First Submitted QC: 2021-02-02
• Study First Posted: 2021-02-03
• Status Verified: 2021-04
• Primary Completion: 2021-09-01
• Last Update Submitted: 2021-10-08
• Last Update Posted: 2021-10-11
• Study Completion: 2021-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 288

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Noncardiac surgery	Preoperative HbA1c	Documentation of HbA1c in patients undergoing noncardiac surgery under general anesthesia

Primary Outcome Measures

Name	Time	Method
Incidence of Postoperative Neurocognitive Disorders assessed with CAM	1st postoperative day	Screening for POD assessed with CAM
Incidence of Postoperative Neurocognitive Disorders with IQCODE-16	9 months postoperatively	Screening for POCD with IQCODE-16

Trial Locations

Locations (1)

University of Thessaly; 🇬🇷 Larissa, Greece