HbA1c and Neurocognitive Disorders

NCT ID: NCT04736277

Last Updated: 2021-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

288 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-01

Study Completion Date

2021-11-01

Brief Summary

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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

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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.

Conditions

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Neurocognitive Disorders HbA1c

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Noncardiac surgery

Documentation of HbA1c in patients undergoing noncardiac surgery under general anesthesia

Preoperative HbA1c

Intervention Type OTHER

Documentation of the preopetative HbA1c in patients undergoing noncardiac surgery under general anesthesia

Interventions

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Preoperative HbA1c

Documentation of the preopetative HbA1c in patients undergoing noncardiac surgery under general anesthesia

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ioannina

OTHER

Sponsor Role collaborator

Larissa University Hospital

OTHER

Sponsor Role collaborator

University of Thessaly

OTHER

Sponsor Role lead

Responsible Party

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Elena Arnaoutoglou

Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eleni Arnaoutoglou, MD, PhD

Role: STUDY_CHAIR

Professor of Anesthesiology

Maria Ntalouka, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Consultant of Anesthesiology

Locations

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University of Thessaly

Larissa, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Maria Ntalouka, MD, PhD

Role: CONTACT

+306973688099

Metaxia Bareka, MD, PhD

Role: CONTACT

+306947845083

Facility Contacts

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Eleni Arnaoutoglou, MD, PhD

Role: primary

+306974301352

Maria Ntalouka, MD, PhD

Role: backup

+306973688099

Other Identifiers

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HbA1c and NCD

Identifier Type: -

Identifier Source: org_study_id

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