HbA1c and Neurocognitive Disorders

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

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 Overview

• Status: Recruiting
• Conditions: Neurocognitive Disorders; HbA1c
• Intervention / Treatment: Other: Preoperative HbA1c

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 Type: Observational
• Enrollment (Anticipated): 288

Contacts and Locations

Study Locations

• Greece
  • Larissa, Greece, 41335
    • Recruiting
    • University of Thessaly
    • Sub-Investigator: Petros Tzimas, MD, PhD
    • Sub-Investigator: Alexandros Brotis, MD, PhD
    • Sub-Investigator: Fragkiskos Angelis, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

- All patients 45 - 80 years old, ASA I-III undergoing elective general, urological, gynecological and orthopedic surgery under general anesthesia

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Noncardiac surgery; Documentation of HbA1c in patients undergoing noncardiac surgery under general anesthesia	Other: Preoperative HbA1c; Documentation of the preopetative HbA1c in patients undergoing noncardiac surgery under general anesthesia

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

Collaborators and Investigators

• Sponsor: University of Thessaly
• Collaborators: Larissa University Hospital; University Hospital, Ioannina
• Investigators: Study Chair: Eleni Arnaoutoglou, MD, PhD, Professor of Anesthesiology; Principal Investigator: Maria Ntalouka, MD, PhD, Consultant of Anesthesiology

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): September 1, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: October 24, 2020
• First Submitted That Met QC Criteria: February 2, 2021
• First Posted (Actual): February 3, 2021

Study Record Updates

• Last Update Posted (Actual): October 11, 2021
• Last Update Submitted That Met QC Criteria: October 8, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders
• Other Study ID Numbers: HbA1c and NCD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No