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Association of Inflammatory Markers With Preoperative Anxiety and Agitation

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06648122
Enrollment
350
Registered
2024-10-18
Start date
2024-10-21
Completion date
2025-07-30
Last updated
2025-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Agitation, Preoperative Anxiety

Keywords

Children, Preoperative anxiety, Emergence agitation, Inflammation

Brief summary

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

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.

Interventions

OTHERlaboratory results

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)

Sponsors

Cukurova University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
PAED scorefirst 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

MeasureTime frameDescription
mYPAS score15 minutes before surgery in the preoperative unitThe 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.
Demographic datauntil the completion of surgeryAge (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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 19, 2026