Delirium - PostoperativeNCT06701643
Can Neutrophil-to-Lymphocyte Ratio, Platelet Volume and Platelet Distribution Width Be Used as Indicators of Delirium?
An observational study of Delirium - Postoperative, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Postoperative delirium is a frequent complication in children undergoing general anesthesia. It has been suggested that inflammation and oxidative stress contribute to the pathophysiology of delirium. Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Delirium - Postoperative
- How many people
- 221 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Nov 2022to 14 Feb 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 9 years
- All sexes
- No healthy volunteers
- Child
Study population: This single-center study, took place in Ankara Bilkent City Hospital's operating rooms and postoperative care unit. Children undergoing adenoidectomy, tonsillectomy, and/or ventilation tube placement were followed up.
Who may be able to join
- ASA I-III risk group
- Planned to have adenoidectomy, tonsillectomy, and/or ventilation tube placement.
Who cannot join
- Children under 3 years old
- Children over 9 years old
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital, Department of Anesthesiology
Ankara, 06800
About this study
Postoperative delirium is a frequent complication in children undergoing general anesthesia. It has been suggested that inflammation and oxidative stress contribute to the pathophysiology of delirium. The aim of this prospective observational study was to investigate the relationship between inflammatory markers, and delirium. The main questions it aimed to answer were:
- 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?
Read the detailed description
Postoperative delirium is a frequent complication in children undergoing general anesthesia. It has been suggested that inflammation and oxidative stress contribute to the pathophysiology of delirium. The aim of our study was to investigate the relationship between inflammatory markers, and delirium.
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
- Delirium - Postoperative
- Keywords
- postoperative delirium, children, general anesthesia, neutrophil-to-lymphocyte ratio
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutrophil-to-lymphocyte ratio in the study group including patients with and without delirium
Preoperative Neutrophil-to-lymphocyte ratio recorded from routine preoperative blood tests.
Measured: Preoperatively, at the preoperative assessment
Platelet volume in the study group including patients with and without delirium
Preoperative Platelet volume recorded from routine preoperative blood tests.
Measured: Preoperatively, at the preoperative assessment
Platelet Distribution Width in the study group including patients with and without delirium
Preoperative Platelet Distribution Width recorded from routine preoperative blood tests.
Measured: Preoperatively, at the preoperative assessment
Incidence of postoperative delirium
Patients are followed up for 30 minutes postoperatively and delirium is detected via The Pediatric Anesthesia Emergence Delirium (PAED) Score. 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.
Measured: 30 minutes postoperatively
Secondary outcomes (1)
Incidence of postoperative pain
Patients are followed up for 30 minutes postoperatively and patients' pain was assessed using the Face, Legs, Activity, Cry, and Consolability (FLACC) 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
Measured: 30 minutes postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start14 Nov 2022
- Primary completion14 Feb 2024
- Study completion14 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Delirium - PostoperativeStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 221 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ezgi Erkilic, Associate Professor, Principal investigator, Ankara Bilkent City Hospital, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701643
- Sponsor's protocol ID
- E1-23-3197
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared after publication of the study. Study protocol, statistical analysis, study report will be shared if required by a researcher.
Publications
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.
PubMed 33084189Vlajkovic 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.
PubMed 17179249Sikich 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.
PubMed 15114210Zielinski 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.
PubMed 32129952Feng 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.
PubMed 38267728Moore AD, Anghelescu DL. Emergence Delirium in Pediatric Anesthesia. Paediatr Drugs. 2017 Feb;19(1):11-20. doi: 10.1007/s40272-016-0201-5.
PubMed 27798810
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Neutrophil-to-Lymphocyte Ratio, Platelet Volume and Platelet Distribution Width Be Used as Indicators of Delirium?
- ClinicalTrials.gov ID
- NCT06701643
- Acronym / sponsor ID
- E1-23-3197
- Conditions
- Delirium - Postoperative
- Keywords
- postoperative delirium, children, general anesthesia, neutrophil-to-lymphocyte ratio
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 14 Feb 2024 (actual)
- Study completion
- 14 Feb 2024 (actual)
- First posted
- 22 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative delirium is a frequent complication in children undergoing general anesthesia. It has been suggested that inflammation and oxidative stress contribute to the pathophysiology of delirium. The aim of this prospective observational study was to investigate the relationship between inflammatory markers, and delirium. The main questions it aimed to answer were:
- 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?
Detailed description
Postoperative delirium is a frequent complication in children undergoing general anesthesia. It has been suggested that inflammation and oxidative stress contribute to the pathophysiology of delirium. The aim of our study was to investigate the relationship between inflammatory markers, and delirium.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This single-center study, took place in Ankara Bilkent City Hospital's operating rooms and postoperative care unit. Children undergoing adenoidectomy, tonsillectomy, and/or ventilation tube placement were followed up.
Key inclusion criteria (2 listed)
- ASA I-III risk group
- Planned to have adenoidectomy, tonsillectomy, and/or ventilation tube placement.
Key exclusion criteria (2 listed)
- Children under 3 years old
- Children over 9 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neutrophil-to-lymphocyte ratio in the study group including patients with and without delirium
Time frame: Preoperatively, at the preoperative assessment
Preoperative Neutrophil-to-lymphocyte ratio recorded from routine preoperative blood tests.
Platelet volume in the study group including patients with and without delirium
Time frame: Preoperatively, at the preoperative assessment
Preoperative Platelet volume recorded from routine preoperative blood tests.
Platelet Distribution Width in the study group including patients with and without delirium
Time frame: Preoperatively, at the preoperative assessment
Preoperative Platelet Distribution Width recorded from routine preoperative blood tests.
Incidence of postoperative delirium
Time frame: 30 minutes postoperatively
Patients are followed up for 30 minutes postoperatively and delirium is detected via The Pediatric Anesthesia Emergence Delirium (PAED) Score. 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.
1 secondary outcome
Incidence of postoperative pain
Time frame: 30 minutes postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Results publication: PubMed 33084189Ida 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.
- Results publication: PubMed 17179249Vlajkovic 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.
- Results publication: PubMed 15114210Sikich 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.
- Results publication: PubMed 32129952Zielinski 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.
- Results publication: PubMed 38267728Feng 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.
- Results publication: PubMed 27798810Moore AD, Anghelescu DL. Emergence Delirium in Pediatric Anesthesia. Paediatr Drugs. 2017 Feb;19(1):11-20. doi: 10.1007/s40272-016-0201-5.
- Individual participant dataSharing planned: Yes. Data will be shared after publication of the study. Study protocol, statistical analysis, study report will be shared if required by a researcher.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ezgi Erkilic, Associate Professor principal investigator
Ankara Bilkent City Hospital, Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium - Postoperative, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neutrophil-to-lymphocyte ratio in the study group including patients with and without delirium (time frame: Preoperatively, at the preoperative assessment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06701643, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.