Clinical trial NCT06648122: Association of Inflammatory Markers with Preoperative Anxiety and Agitation
Official title: Association of Preoperative Inflammatory Markers with Preoperative Anxiety and Emergence Agitation in Children
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Preoperative Anxiety
Emergence Agitation
Keywords: Children
Preoperative anxiety
Emergence agitation
Inflammation
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2024-10-18
Enrollment: 210
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children who will undergo surgery

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.

Eligibility criteria: 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.

Primary outcomes:
measure: PAED score
timeFrame: first 30 minutes in the postoperative unit.
Secondary outcomes:
measure: mYPAS score
timeFrame: 15 minutes before surgery in the preoperative unit
measure: Demographic data
timeFrame: until the completion of surgery
Other outcomes:
Locations:
Study officials:
References: