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

NCT06701643 | Completed

• 1 other identifier: E1-23-3197
• Study Type: observational
• Target: 221
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Delirium - Postoperative

Keywords

postoperative delirium; children; general anesthesia; neutrophil-to-lymphocyte ratio

Outcome Measures

Primary Outcomes (4)

• Neutrophil-to-lymphocyte ratio in the study group including patients with and without delirium

  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

  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

  Preoperative Platelet Distribution Width recorded from routine preoperative blood tests.

  Preoperatively, at the preoperative assessment

• Incidence of postoperative delirium

  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 Outcomes (1)

• Incidence of postoperative pain

  30 minutes postoperatively

Study Arms (1)

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.

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital, Department of Anesthesiology

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (6)

• Ida M, Takeshita Y, Kawaguchi M. Preoperative serum biomarkers in the prediction of postoperative delirium following abdominal surgery. Geriatr Gerontol Int. 2020 Dec;20(12):1208-1212. doi: 10.1111/ggi.14066. Epub 2020 Oct 21.

  PMID: 33084189 RESULT

• Vlajkovic GP, Sindjelic RP. Emergence delirium in children: many questions, few answers. Anesth Analg. 2007 Jan;104(1):84-91. doi: 10.1213/01.ane.0000250914.91881.a8.

  PMID: 17179249 RESULT

• Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015.

  PMID: 15114210 RESULT

• Zielinski J, Morawska-Kochman M, Zatonski T. Pain assessment and management in children in the postoperative period: A review of the most commonly used postoperative pain assessment tools, new diagnostic methods and the latest guidelines for postoperative pain therapy in children. Adv Clin Exp Med. 2020 Mar;29(3):365-374. doi: 10.17219/acem/112600.

  PMID: 32129952 RESULT

• Feng B, Guo Y, Tang S, Zhang T, Gao Y, Ni X. Association of preoperative neutrophil-lymphocyte ratios with the emergence delirium in pediatric patients after tonsillectomy and adenoidectomy: an observational prospective study. J Anesth. 2024 Apr;38(2):206-214. doi: 10.1007/s00540-023-03303-3. Epub 2024 Jan 24.

  PMID: 38267728 RESULT

• Moore AD, Anghelescu DL. Emergence Delirium in Pediatric Anesthesia. Paediatr Drugs. 2017 Feb;19(1):11-20. doi: 10.1007/s40272-016-0201-5.

  PMID: 27798810 RESULT

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ezgi Erkilic, Associate Professor

  Ankara Bilkent City Hospital, Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 22, 2024
• Study Start: November 14, 2022
• Primary Completion: February 14, 2024
• Study Completion: February 14, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Beginning right after publication and ending 2 years after the publication of results
• Access Criteria: Data required for researches will be shared

Locations

TU (1)