NLR and PRL in Neurocognitive Disorders

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

Preliminary evidence suggest a possible relationship between Neutrophil-Lymphocyte Ratio (NLR) and Platelet-Lymphocyte Ratio (PLR) and perioperative neurocognitive disorders (NCD). We are going to investigate whether the values of NLR and PLR 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; Neutrophil-Lymphocyte Ratio; Platelet-Lymphocyte Ratio
• Intervention / Treatment: Other: NLR; Other: PLR

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 Neutrophil-Lymphocyte Ratio (NLR) and Platelet-Lymphocyte Ratio (PLR) and perioperative neurocognitive disorders (NCD). We are going to investigate whether the values of NLR and PLR 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: 41 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• 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:

• 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

Exclusion Criteria:

• 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)
• or desaturation (one or more events of SpO2 < 80% for more than 2 minutes) peri-operatively
• or blood loss of more than one unit

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Noncardiac surgery; Calculation of the NLR and PLR in patients undergoing noncardiac surgery under general anesthesia	Other: NLR; Calculation of NLR; Other: PLR; Calculation of PLR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Postoperative neurocognitive disorders assessed with CAM	Incidence of POD assessed with CAM	1st postoperative day
Incidence of Postoperative neurocognitive disorders assessed with IQCODE-16	Incidence of POCD assessed with IQCODE-16	10th postoperative day
Incidence of Postoperative neurocognitive disorders assessed with IQCODE-16	Incidence of POCD assessed with IQCODE-16	3 months postoperatively
Incidence of Postoperative neurocognitive disorders assessed with IQCODE-16	Incidence of POCD assessed with IQCODE-16	6 months postoperatively
Incidence of Postoperative neurocognitive disorders assessed with IQCODE-16	Incidence of POCD assessed 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 (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 30, 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): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Neurocognitive disorders; Neutrophil-Lymphocyte ratio; Platelet-Lymphocyte ratio
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Neurocognitive Disorders
• Other Study ID Numbers: NLR, PLR 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