Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648122
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Association of Inflammatory Markers with Preoperative Anxiety and Agitation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Association of Preoperative Inflammatory Markers with Preoperative Anxiety and Emergence Agitation in Children
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None