NCT04736277

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
288

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 3, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

October 11, 2021

Status Verified

April 1, 2021

Enrollment Period

5.8 years

First QC Date

October 24, 2020

Last Update Submit

October 8, 2021

Conditions

Neurocognitive DisordersHbA1c

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (1)

Noncardiac surgery

Documentation of HbA1c in patients undergoing noncardiac surgery under general anesthesia

Other: Preoperative HbA1c

Interventions

Preoperative HbA1cOTHER

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

Noncardiac surgery

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • \) 45 - 80 years
  • \) American Society of Anesthesiologists physical status I to III
  • \) elective general, urological, gynecological and orthopedic surgery under general anesthesia
  • \) native speakers of the Greek language

You may not qualify if:

  • \) refused to participate or sign the informed consent form
  • \) had undergone surgery or anesthesia within the last 30 days
  • \) had any prior or current history involving an affliction of the central nervous system
  • \) were diagnosed with severe cognitive decline based on the 16 - item Informant Questionnaire on Cognitive Decline (IQCODE - 16)
  • \) suffered from severe hearing or visual impairment
  • \) any psychiatric disorder
  • \) had a score \>5 in the Geriatric Depression Scale (GDS - 15)
  • \) or a score in females \< 4 males \< 2 in the Lawton - Brody Instrumental Activities of Daily Living Scale (I.A.D.L.)
  • \) reported alcohol consumption \> 35 units/week
  • \) drug dependence
  • \) had undergone previous neuropsychological testing
  • \) Diabetes Mellitus type II with \> 10 years of diagnosis
  • \) Diabetes Mellitus type I
  • \) Hemoglobin A1c (HbA1c) \> 7.5%
  • \) suffered from hemodynamical instability (\> 20% alterations of blood pressure perioperatively)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Thessaly

Larissa, 41335, Greece

RECRUITING

MeSH Terms

Conditions

Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Eleni Arnaoutoglou, MD, PhD

    Professor of Anesthesiology

    STUDY CHAIR

  • Maria Ntalouka, MD, PhD

    Consultant of Anesthesiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Ntalouka, MD, PhD

CONTACT

+306973688099maria.ntalouka@icloud.com

Metaxia Bareka, MD, PhD

CONTACT

+306947845083barekametaxia@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

October 24, 2020

First Posted

February 3, 2021

Study Start

December 1, 2015

Primary Completion

September 1, 2021

Study Completion

November 1, 2021

Last Updated

October 11, 2021

Record last verified: 2021-04

Locations

GR(1)