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Completed

NCT Number: NCT06648122

Association of Inflammatory Markers With Preoperative Anxiety and Agitation

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

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Key information

Conditions

Preoperative Anxiety Confusion Delirium Emergence Agitation Emergence Delirium Inflammation Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cukurova University, Faculty of Medicine, Department of Anesthesiology

Adana, Turkey, 01380, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

laboratory results

Other

evaluation of laboratory results (hemogram results:WBC, RBC, Hematocrit, Monocyte count, Neutrophil count, Lymphocyte count, Platelet count, PDW, MPV, MLR, NLR, NMR, PLR, PMR, PNR, PWR, SII)

Primary outcomes

  1. PAED score

    Time frame: first 30 minutes in the postoperative unit.

    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.

Secondary outcomes

  1. mYPAS score

    Time frame: 15 minutes before surgery in the preoperative unit

    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.

  2. Demographic data

    Time frame: until the completion of surgery

    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.

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 18, 2024
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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