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Clinical Trials/NCT06648122
NCT06648122
Completed
Not Applicable

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

Cukurova University1 site in 1 country350 target enrollmentOctober 21, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preoperative Anxiety
Sponsor
Cukurova University
Enrollment
350
Locations
1
Primary Endpoint
PAED score
Status
Completed
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 21, 2024
End Date
July 30, 2025
Last Updated
9 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zehra Hatipoglu, MD

MD

Cukurova University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

  • mYPAS score(15 minutes before surgery in the preoperative unit)
  • Demographic data(until the completion of surgery)

Study Sites (1)

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