Association of Inflammatory Markers With Preoperative Anxiety and Agitation

Association of Preoperative Inflammatory Markers With Preoperative Anxiety and Emergence Agitation in Children

This study was planned as a prospective, observational study. The study will include pediatric patients aged 3-12 who will undergo surgery. Our hypothesis is that haemogram parameters, which are a simple, cheap and accessible method, and the inflammatory markers we obtain from them are associated with preoperative anxiety and emergence delirium

Study Overview

• Status: Completed
• Conditions: Preoperative Anxiety; Emergence Agitation
• Intervention / Treatment: Other: laboratory results

Detailed Description

Inclusion criteria for the study: Pediatric patients aged 5-12 years, in the ASA I-II groups, who will undergo surgery in ophthalmology, urological surgery, ENT surgery, pediatric surgery, orthopedic and plastic surgery. Exclusion criteria for the study can be listed as follows: Those with genetic diseases affecting brain development, those diagnosed with psychiatric and neurological diseases, patients with attention deficit, mental retardation, those with hematological and/or immune system disorders, patients who will undergo surgery in neurosurgery and cardiovascular surgery.

During the preoperative visit, parents and children will be informed and their written and verbal consent will be obtained. Patients will be taken to the preoperative waiting room and hemogram values and ratios (WBC, RBC, Hematocrit, Monocyte count, Neutrophil count, Lymphocyte count, Platelet count, PDW, MPV, MLR, NLR, NMR, PLR, PMR, PNR, PWR, SII) will be recorded from medical records. Demographic data (including age, gender, BMI, ASA score, fasting time, previous surgery, hospitalization status, the use of steroid), preoperative anxiety score (to be assessed with m-YPAS Turkish version), parental accompaniment, anxiety score of the parent (to be assessed with Likert scale), preoperative medication application, medications used in anesthesia, airway device, surgery and anesthesia durations will be recorded. The PAED score will be used for delirium agitation and all values will be recorded during the first 30 min. Pain scores (FLACC and VAS) will be recorded in the case report form.

• Study Type: Observational
• Enrollment (Actual): 350

Contacts and Locations

Study Locations

• Turkey
  • Adana, Turkey, 01380
    • Cukurova University, Faculty of Medicine, Department of Anesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Children who will undergo surgery

Description

Inclusion criteria:

• Pediatric patients aged 5-12 years
• ASA I-II groups
• Pediatric patients who will undergo surgery in ophthalmology, urological surgery, ENT surgery, pediatric surgery, orthopedic and plastic surgery.

Exclusion criteria:

• Those with genetic disorders affecting brain development
• Those diagnosed with psychiatric and neurological diseases
• Patients with attention deficit, mental retardation
• Patients with hematological and/or immune system disorders
• Patients who will undergo surgery in neurosurgery and cardiovascular surgery.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PAED score	Emergence agitation will be evaluated in the postoperative unit with PAED scoring. PAED (Paediatric Emergence Delirium) parameters includes child makes eye contact with caregiver, child's actions are purposeful, child is aware of his/her surroundings, child is restless, child is inconsolable.All items are scored on a 0-4 point scale as occurring not at all, just a little, quite a bit, very much, If the sum of the five-parameter scale scores is ≥ 10, emergence agitation can be mentioned.	first 30 minutes in the postoperative unit.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mYPAS score	The Turkish version of the mYPAS (modified yale properative anxiety score) (Scores: min:23.3-max:100) scoring system will be used to assess preoperative anxiety in the preoperative unit. This score to be applied to each patient includes five categories and is applied observationally. The calculation of this score is as follows: (activity / 4 + emotional expression / 4 + the state of arousal / 4 + use of parents / 4 + vocalization / 6) × 100 / 5. Patients with m-YPAS≥40 will be considered anxious.	15 minutes before surgery in the preoperative unit
Demographic data	Age (year), gender, weight (kg) height (cm), BMI (kg/m2), previous surgery, fasting time, hospitalization state, parental accompaniment, score of the parent anxiety (to be assessed with Likert scale), preoperative medication application, drugs used in anesthesia, surgery and anesthesia durations, pain scores will be assessed.	until the completion of surgery

Collaborators and Investigators

• Sponsor: Cukurova University

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2024
• Primary Completion (Actual): July 30, 2025
• Study Completion (Actual): July 30, 2025

Study Registration Dates

• First Submitted: October 8, 2024
• First Submitted That Met QC Criteria: October 17, 2024
• First Posted (Actual): October 18, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Inflammation; Children; Preoperative anxiety; Emergence agitation
• Additional Relevant MeSH Terms: Aberrant Motor Behavior in Dementia; Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Behavioral Symptoms; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Dyskinesias; Psychomotor Disorders; Delirium; Emergence Delirium; Anxiety Disorders; Psychomotor Agitation
• Other Study ID Numbers: 09/2024;5

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No