NCT06648122

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 18, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

October 21, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

9 months

First QC Date

October 8, 2024

Last Update Submit

July 30, 2025

Conditions

Keywords

ChildrenPreoperative anxietyEmergence agitationInflammation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • mYPAS score

    15 minutes before surgery in the preoperative unit

  • Demographic data

    until the completion of surgery

Interventions

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)

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children who will undergo surgery

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University, Faculty of Medicine, Department of Anesthesiology

Adana, Turkey, 01380, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Emergence DeliriumInflammation

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 8, 2024

First Posted

October 18, 2024

Study Start

October 21, 2024

Primary Completion

July 30, 2025

Study Completion

July 30, 2025

Last Updated

August 1, 2025

Record last verified: 2025-07

Locations