Can Neutrophil-to-Lymphocyte Ratio, Platelet Volume and Platelet Distribution Width Be Used as Indicators of Delirium?
NCT ID: NCT06701643
Last Updated: 2024-11-22
Study Results
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Basic Information
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COMPLETED
221 participants
OBSERVATIONAL
2022-11-14
2024-02-14
Brief Summary
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* Is there a realtionship between delirium and neutrophil-to-lymphocyte ratio?
* Is there a realtionship between delirium and platelet volume?
* Is there a realtionship between delirium and platelet distribution width?
* What is the incidence of postoperative delirium in the study group?
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Detailed Description
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This single-center, prospective, and observational study included 221 children aged 3 to 9 years in the ASA 1-3 risk group who underwent adenoidectomy, tonsillectomy, and/or ventilation tube placement. Consent was obtained from the parents, and patients were either premedicated with oral midazolam in the preoperative period or taken to surgery without premedication, depending on the anesthesiologist's preference. After induction with sevoflurane, intravenous access was established, and fentanyl (1 µg.kg-1) and rocuronium (0.6 mg.kg-1) were administered. Following intubation, maintenance was achieved with sevoflurane, 50% oxygen, 50% air, and a remifentanil infusion at 0.1-0.15 µg.kg-1.min-1. Additionally, all children received intravenous paracetamol (15 mg.kg-1), methylprednisolone (1 mg.kg-1), and ondansetron (0.1 mg.kg-1). At the end of the operation, the muscle relaxant effect was reversed with sugammadex at 2 mg.kg-1. Following extubation, patients were transferred to the post-anesthesia recovery unit and monitored for 30 minutes in the presence of their parents. In the postoperative period, patients' pain was assessed using the Face, Legs, Activity, Cry, and Consolability (FLACC) Scale, and the presence of delirium was evaluated with the Pediatric Anesthesia Emergence Delirium (PAED) Scale.
The FLACC Scale is used to assess the intensity of postoperative pain in young children, infants, or those unable to communicate. Each parameter is assessed on a scale from 0 to 2, with the total score interpreted as follows: 0 = relaxed and comfortable, 1-3 = mild discomfort, 4-6 = moderate pain, and 7-10 = severe discomfort/pain. A score greater than 3 indicates a need for analgesics In our study, ibuprofen was administered to patients experiencing pain within the first 30 minutes of the postoperative period.
The Pediatric Anesthesia Emergence Delirium (PAED) Scale is the only validated tool for measuring delirium and agitation in the postoperative period. The PAED score is used to assess delirium after the patient awakens and prior to the administration of medication, in order to differentiate pain from delirium. Accordingly, the PAED score is determined by evaluating each category-eye contact, purposeful movements, awareness of surroundings, restlessness, and inconsolability-on a scale from 0 to 4. A total score equal to or greater than 10 indicates the presence of delirium. In our study, all patients were assessed using the PAED scoring system in the postoperative period, and those with a score of 10 or higher were considered to have delirium.
Complete blood count values that are routinely measured in the preoperative period were recorded for all patients.
Statistical analysis Data analysis was performed using the R Studio package program (RStudio Team (2020), Integrated Development for R. RStudio, PBC, Boston, MA, http://www.rstudio.com/ ). In our descriptive analyses, quantitative data were expressed as mean and standard deviation, while qualitative categorical variables were presented as case numbers and percentages (%). In the analysis of NLR levels in patients classified as having delirium, tests for normal distribution and homogeneity of variance were conducted to ensure the assumptions for the Student's t-test were met. Shapiro-Wilk normality tests were performed for the "Yes" and "No" groups. The Student's t-test was used to compare the mean NLR levels between the two groups. The association between the need for analgesics and the presence of delirium in children was evaluated using the Pearson chi-square test with Yates continuity correction.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients undergoing adenoidectomy, tonsillectomy and/or ventilation tube application
Patients undergoing adenoidectomy, tonsillectomy and/or ventilation tube application either premedicated or not, with ASA I-III risk group, followed up for 30 minutes postoperatively.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Planned to have adenoidectomy, tonsillectomy, and/or ventilation tube placement.
Exclusion Criteria
* Children over 9 years old
3 Years
9 Years
ALL
No
Sponsors
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Ankara City Hospital Bilkent
OTHER
Responsible Party
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Principal Investigators
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Ezgi Erkilic, Associate Professor
Role: PRINCIPAL_INVESTIGATOR
Ankara Bilkent City Hospital, Department of Anesthesiology
Locations
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Ankara Bilkent City Hospital, Department of Anesthesiology
Ankara, , Turkey (Türkiye)
Countries
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References
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Ida M, Takeshita Y, Kawaguchi M. Preoperative serum biomarkers in the prediction of postoperative delirium following abdominal surgery. Geriatr Gerontol Int. 2020 Dec;20(12):1208-1212. doi: 10.1111/ggi.14066. Epub 2020 Oct 21.
Vlajkovic GP, Sindjelic RP. Emergence delirium in children: many questions, few answers. Anesth Analg. 2007 Jan;104(1):84-91. doi: 10.1213/01.ane.0000250914.91881.a8.
Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015.
Zielinski J, Morawska-Kochman M, Zatonski T. Pain assessment and management in children in the postoperative period: A review of the most commonly used postoperative pain assessment tools, new diagnostic methods and the latest guidelines for postoperative pain therapy in children. Adv Clin Exp Med. 2020 Mar;29(3):365-374. doi: 10.17219/acem/112600.
Feng B, Guo Y, Tang S, Zhang T, Gao Y, Ni X. Association of preoperative neutrophil-lymphocyte ratios with the emergence delirium in pediatric patients after tonsillectomy and adenoidectomy: an observational prospective study. J Anesth. 2024 Apr;38(2):206-214. doi: 10.1007/s00540-023-03303-3. Epub 2024 Jan 24.
Moore AD, Anghelescu DL. Emergence Delirium in Pediatric Anesthesia. Paediatr Drugs. 2017 Feb;19(1):11-20. doi: 10.1007/s40272-016-0201-5.
Other Identifiers
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E1-23-3197
Identifier Type: -
Identifier Source: org_study_id
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