Can Neutrophil-to-Lymphocyte Ratio, Platelet Volume and Platelet Distribution Width Be Used as Indicators of Delirium?

November 21, 2024 updated by: Ankara City Hospital Bilkent

Postoperative delirium is a frequent complication in children undergoing general anesthesia. It has been suggested that inflammation and oxidative stress contribute to the pathophysiology of delirium. The aim of this prospective observational study was to investigate the relationship between inflammatory markers, and delirium. The main questions it aimed to answer were:

  • Is there a realtionship between delirium and neutrophil-to-lymphocyte ratio?
  • Is there a realtionship between delirium and platelet volume?
  • Is there a realtionship between delirium and platelet distribution width?
  • What is the incidence of postoperative delirium in the study group?

Study Overview

Status

Completed

Detailed Description

Postoperative delirium is a frequent complication in children undergoing general anesthesia. It has been suggested that inflammation and oxidative stress contribute to the pathophysiology of delirium. The aim of our study was to investigate the relationship between inflammatory markers, and delirium.

This single-center, prospective, and observational study included 221 children aged 3 to 9 years in the ASA 1-3 risk group who underwent adenoidectomy, tonsillectomy, and/or ventilation tube placement. Consent was obtained from the parents, and patients were either premedicated with oral midazolam in the preoperative period or taken to surgery without premedication, depending on the anesthesiologist's preference. After induction with sevoflurane, intravenous access was established, and fentanyl (1 µg.kg-1) and rocuronium (0.6 mg.kg-1) were administered. Following intubation, maintenance was achieved with sevoflurane, 50% oxygen, 50% air, and a remifentanil infusion at 0.1-0.15 µg.kg-1.min-1. Additionally, all children received intravenous paracetamol (15 mg.kg-1), methylprednisolone (1 mg.kg-1), and ondansetron (0.1 mg.kg-1). At the end of the operation, the muscle relaxant effect was reversed with sugammadex at 2 mg.kg-1. Following extubation, patients were transferred to the post-anesthesia recovery unit and monitored for 30 minutes in the presence of their parents. In the postoperative period, patients' pain was assessed using the Face, Legs, Activity, Cry, and Consolability (FLACC) Scale, and the presence of delirium was evaluated with the Pediatric Anesthesia Emergence Delirium (PAED) Scale.

The FLACC Scale is used to assess the intensity of postoperative pain in young children, infants, or those unable to communicate. Each parameter is assessed on a scale from 0 to 2, with the total score interpreted as follows: 0 = relaxed and comfortable, 1-3 = mild discomfort, 4-6 = moderate pain, and 7-10 = severe discomfort/pain. A score greater than 3 indicates a need for analgesics In our study, ibuprofen was administered to patients experiencing pain within the first 30 minutes of the postoperative period.

The Pediatric Anesthesia Emergence Delirium (PAED) Scale is the only validated tool for measuring delirium and agitation in the postoperative period. The PAED score is used to assess delirium after the patient awakens and prior to the administration of medication, in order to differentiate pain from delirium. Accordingly, the PAED score is determined by evaluating each category-eye contact, purposeful movements, awareness of surroundings, restlessness, and inconsolability-on a scale from 0 to 4. A total score equal to or greater than 10 indicates the presence of delirium. In our study, all patients were assessed using the PAED scoring system in the postoperative period, and those with a score of 10 or higher were considered to have delirium.

Complete blood count values that are routinely measured in the preoperative period were recorded for all patients.

Statistical analysis Data analysis was performed using the R Studio package program (RStudio Team (2020), Integrated Development for R. RStudio, PBC, Boston, MA, http://www.rstudio.com/ ). In our descriptive analyses, quantitative data were expressed as mean and standard deviation, while qualitative categorical variables were presented as case numbers and percentages (%). In the analysis of NLR levels in patients classified as having delirium, tests for normal distribution and homogeneity of variance were conducted to ensure the assumptions for the Student's t-test were met. Shapiro-Wilk normality tests were performed for the "Yes" and "No" groups. The Student's t-test was used to compare the mean NLR levels between the two groups. The association between the need for analgesics and the presence of delirium in children was evaluated using the Pearson chi-square test with Yates continuity correction.

Study Type

Observational

Enrollment (Actual)

221

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ankara, Turkey, 06800
        • Ankara Bilkent City Hospital, Department of Anesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This single-center study, took place in Ankara Bilkent City Hospital's operating rooms and postoperative care unit. Children undergoing adenoidectomy, tonsillectomy, and/or ventilation tube placement were followed up.

Description

Inclusion Criteria:

  • ASA I-III risk group
  • Planned to have adenoidectomy, tonsillectomy, and/or ventilation tube placement.

Exclusion Criteria:

  • Children under 3 years old
  • Children over 9 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients undergoing adenoidectomy, tonsillectomy and/or ventilation tube application
Patients undergoing adenoidectomy, tonsillectomy and/or ventilation tube application either premedicated or not, with ASA I-III risk group, followed up for 30 minutes postoperatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neutrophil-to-lymphocyte ratio in the study group including patients with and without delirium
Time Frame: Preoperatively, at the preoperative assessment
Preoperative Neutrophil-to-lymphocyte ratio recorded from routine preoperative blood tests.
Preoperatively, at the preoperative assessment
Platelet volume in the study group including patients with and without delirium
Time Frame: Preoperatively, at the preoperative assessment
Preoperative Platelet volume recorded from routine preoperative blood tests.
Preoperatively, at the preoperative assessment
Platelet Distribution Width in the study group including patients with and without delirium
Time Frame: Preoperatively, at the preoperative assessment
Preoperative Platelet Distribution Width recorded from routine preoperative blood tests.
Preoperatively, at the preoperative assessment
Incidence of postoperative delirium
Time Frame: 30 minutes postoperatively
Patients are followed up for 30 minutes postoperatively and delirium is detected via The Pediatric Anesthesia Emergence Delirium (PAED) Score. PAED score is determined by evaluating each category-eye contact, purposeful movements, awareness of surroundings, restlessness, and inconsolability-on a scale from 0 to 4. A total score equal to or greater than 10 indicates the presence of delirium (. In our study, all patients were assessed using the PAED scoring system in the postoperative period, and those with a score of 10 or higher were considered to have delirium.
30 minutes postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of postoperative pain
Time Frame: 30 minutes postoperatively
Patients are followed up for 30 minutes postoperatively and patients' pain was assessed using the Face, Legs, Activity, Cry, and Consolability (FLACC) Scale. The FLACC Scale is used to assess the intensity of postoperative pain in young children, infants, or those unable to communicate. Each parameter is assessed on a scale from 0 to 2, with the total score interpreted as follows: 0 = relaxed and comfortable, 1-3 = mild discomfort, 4-6 = moderate pain, and 7-10 = severe discomfort/pain. A score greater than 3 indicates a need for analgesics
30 minutes postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ezgi Erkilic, Associate Professor, Ankara Bilkent City Hospital, Department of Anesthesiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2022

Primary Completion (Actual)

February 14, 2024

Study Completion (Actual)

February 14, 2024

Study Registration Dates

First Submitted

November 19, 2024

First Submitted That Met QC Criteria

November 21, 2024

First Posted (Estimated)

November 22, 2024

Study Record Updates

Last Update Posted (Estimated)

November 22, 2024

Last Update Submitted That Met QC Criteria

November 21, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared after publication of the study. Study protocol, statistical analysis, study report will be shared if required by a researcher.

IPD Sharing Time Frame

Beginning right after publication and ending 2 years after the publication of results

IPD Sharing Access Criteria

Data required for researches will be shared

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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