Clinical trial NCT04736277: HbA1c and Neurocognitive Disorders
Official title: The Effect of HbA1c on Perioperative Neurocognitive Disorders in Patients Undergoing Elective Non-cardiac Surgery Under General Anesthesia.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neurocognitive Disorders
HbA1c
Lead sponsor: University of Thessaly
Sponsor class: OTHER
Collaborators: name: University Hospital, Ioannina
name: Larissa University Hospital
First posted: 2021-02-03
Enrollment: 288
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
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

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.

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

Primary outcomes:
measure: Incidence of Postoperative Neurocognitive Disorders assessed with CAM
timeFrame: 1st postoperative day
measure: Incidence of Postoperative Neurocognitive Disorders with IQCODE-16
timeFrame: 10th postoperative day
measure: Incidence of Postoperative Neurocognitive Disorders with IQCODE-16
timeFrame: 3 months postoperatively
measure: Incidence of Postoperative Neurocognitive Disorders with IQCODE-16
timeFrame: 6 months postoperatively
measure: Incidence of Postoperative Neurocognitive Disorders with IQCODE-16
timeFrame: 9 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: University of Thessaly
Study officials:
affiliation: Professor of Anesthesiology
name: Eleni Arnaoutoglou, MD, PhD
role: STUDY_CHAIR
affiliation: Consultant of Anesthesiology
name: Maria Ntalouka, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: