HbA1c and Neurocognitive Disorders

Neurocognitive Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04736277
• Other study ID #: HbA1c and NCD
• Status: Recruiting
• Start date: December 1, 2015
• Est. completion date: November 1, 2021

Study information

• Verified date: April 2021
• Source: University of Thessaly
• Contact: Maria Ntalouka, MD, PhD
• Phone: +306973688099
• Email: maria.ntalouka[@]icloud.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. completion date: November 1, 2021
• Est. primary completion date: September 1, 2021
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• HbA1c
• Neurocognitive Disorders

Intervention

Other:
• Preoperative HbA1c
Documentation of the preopetative HbA1c in patients undergoing noncardiac surgery under general anesthesia

Locations

Country	Name	City	State
Greece	University of Thessaly	Larissa

Sponsors (3)

Lead Sponsor	Collaborator
University of Thessaly	Larissa University Hospital, University Hospital, Ioannina

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Postoperative Neurocognitive Disorders assessed with CAM	Screening for POD assessed with CAM	1st postoperative day
Primary	Incidence of Postoperative Neurocognitive Disorders with IQCODE-16	Screening for POCD with IQCODE-16	10th postoperative day
Primary	Incidence of Postoperative Neurocognitive Disorders with IQCODE-16	Screening for POCD with IQCODE-16	3 months postoperatively
Primary	Incidence of Postoperative Neurocognitive Disorders with IQCODE-16	Screening for POCD with IQCODE-16	6 months postoperatively
Primary	Incidence of Postoperative Neurocognitive Disorders with IQCODE-16	Screening for POCD with IQCODE-16	9 months postoperatively