AnesthesiaNLOPEDINCT03756909
Effect of Neutrophil Lymphocyte-platelet Lymphocyte Ratio on Complications in Pediatric Patients
An observational study of Anesthesia and Complication, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the relationship between NLR, PLR and postoperative complications in children undergoing adenotonsillectomy and adenoidectomy. Read more about this study
- Who is it for?
- Ages 2 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Complication
- How many people
- 127 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2018to 1 Nov 2018
- 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 2 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 2-10 years
Who may be able to join
- Patients undergoing elective adenotonsillectomy and adenoidectomy under general anesthesia
Who cannot join
- Immunodeficiency
- Children of parents who do not want to participate in the study
- Use of anticoagulants
- Children with hematological disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adnan Menderes University Training and Research Hospital
Aydin, 09100
About this study
Official title: The Effect of Neutrophil Lymphocyte Ratio and Platelet Lymphocyte Ratio on Intraoperative and Postoperative Complications in Pediatric Patients Undergoing Otolaryngology
The aim of this study was to investigate the relationship between NLR, PLR and postoperative complications in children undergoing adenotonsillectomy and adenoidectomy.
Read the detailed description
Between the dates of February 1, 2018 and June 30, 2018, patients between 2-10 years of age, ASA I-II, elective adenotonsillectomy and adenoidectomy under general anesthesia were planned to be included in the study. The number of neutrophils, lymphocytes and platelets will be taken from the hospital registry system taken preoperatively and the NLR and PLR ratios will be calculated.
All patients in the operating room will be started with routine monitoring and anesthesia. Hemodynamic data during surgery will be recorded. The entrance to the operating room (T1), 5 minutes after the start of anesthesia (T5), 15 minutes (T15), 30 minutes (T30) and 45 minutes (T45) will be recorded in the follow-up form of the anesthesia. The fasting period of the patients and the drugs and fluids applied during surgery will be recorded from the anesthesia form. At the end of the operation, the patients who were taken to the recovery room at the end of the surgery will be evaluated with 1 point, 15 minutes, 30 minutes, 1 hour and 4 hours and 6 hours vomiting using the 4 point nausea scale.
Introduction to recovery room using Modified Eastern Ontario Children's Hospital Pain Scale (mCHEOPS), postoperative pain at 15 min, 30 min, 1 hr and 4 hr. Analgesic requirement will be recorded. Bronchospasm, agitation, etc. will be recorded by evaluating whether there are complications.
- Conditions
- Anesthesia, Complication
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 |
|---|---|---|
| adenoidectomy group | Operations of adenoidectomy | |
| adenotonsillectomy group | Operations of adenotonsillectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect on postoperative complications of neutrophil lymphocyte ratio in adenotonsillectomy and adenoidectomy PAIN
Pain level will be evaluated by using CHEOPS (Children's Hospital of Eastern Ontario Pain Scale ) pain score. The scale includes six categories of pain behavior (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the total score ranges between 4 and 13.
Measured: Postoperative 6 hours
The effect on postoperative complications of neutrophil lymphocyte ratio in adenotonsillectomy and/or adenoidectomy POVN
Pain level will be evaluated by using POVN score. Evaluation of nausea and vomiting was performed by a four-point scale; 0: No nausea and/or vomiting, 1: mild nausea and/or vomiting which does not require treatment, 2: nausea and/or vomiting requiring treatment and 3: vomiting resistant to antiemetic treatment
Measured: Postoperative 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start1 Feb 2018
- Primary completion30 Jun 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe 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
- Cross-sectional
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SİNAN YILMAZ, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756909
- Sponsor's protocol ID
- NLOPEDİ
- Acronym
- NLOPEDI
- Status last verified
- Nov 2018
- First submitted
- 27 Nov 2018
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Neutrophil Lymphocyte Ratio and Platelet Lymphocyte Ratio on Intraoperative and Postoperative Complications in Pediatric Patients Undergoing Otolaryngology
- ClinicalTrials.gov ID
- NCT03756909
- Acronym / sponsor ID
- NLOPEDI / NLOPEDİ
- Conditions
- Anesthesia, Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 28 Nov 2018 (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.
The aim of this study was to investigate the relationship between NLR, PLR and postoperative complications in children undergoing adenotonsillectomy and adenoidectomy.
Detailed description
Between the dates of February 1, 2018 and June 30, 2018, patients between 2-10 years of age, ASA I-II, elective adenotonsillectomy and adenoidectomy under general anesthesia were planned to be included in the study. The number of neutrophils, lymphocytes and platelets will be taken from the hospital registry system taken preoperatively and the NLR and PLR ratios will be calculated.
All patients in the operating room will be started with routine monitoring and anesthesia. Hemodynamic data during surgery will be recorded. The entrance to the operating room (T1), 5 minutes after the start of anesthesia (T5), 15 minutes (T15), 30 minutes (T30) and 45 minutes (T45) will be recorded in the follow-up form of the anesthesia. The fasting period of the patients and the drugs and fluids applied during surgery will be recorded from the anesthesia form. At the end of the operation, the patients who were taken to the recovery room at the end of the surgery will be evaluated with 1 point, 15 minutes, 30 minutes, 1 hour and 4 hours and 6 hours vomiting using the 4 point nausea scale.
Introduction to recovery room using Modified Eastern Ontario Children's Hospital Pain Scale (mCHEOPS), postoperative pain at 15 min, 30 min, 1 hr and 4 hr. Analgesic requirement will be recorded. Bronchospasm, agitation, etc. will be recorded by evaluating whether there are complications.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adenoidectomy group | – | –Operations of adenoidectomy |
| adenotonsillectomy group | – | –Operations of adenotonsillectomy |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 2-10 years
Key inclusion criteria (1 listed)
- Patients undergoing elective adenotonsillectomy and adenoidectomy under general anesthesia
Key exclusion criteria (4 listed)
- Immunodeficiency
- Children of parents who do not want to participate in the study
- Use of anticoagulants
- Children with hematological disease
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
The effect on postoperative complications of neutrophil lymphocyte ratio in adenotonsillectomy and adenoidectomy PAIN
Time frame: Postoperative 6 hours
Pain level will be evaluated by using CHEOPS (Children's Hospital of Eastern Ontario Pain Scale ) pain score. The scale includes six categories of pain behavior (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the total score ranges between 4 and 13.
The effect on postoperative complications of neutrophil lymphocyte ratio in adenotonsillectomy and/or adenoidectomy POVN
Time frame: Postoperative 6 hours
Pain level will be evaluated by using POVN score. Evaluation of nausea and vomiting was performed by a four-point scale; 0: No nausea and/or vomiting, 1: mild nausea and/or vomiting which does not require treatment, 2: nausea and/or vomiting requiring treatment and 3: vomiting resistant to antiemetic treatment
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 29 Nov 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Anesthesia and Complication, run by Aydin Adnan Menderes University 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 1 inclusion and 4 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 29 Nov 2018. 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?
The effect on postoperative complications of neutrophil lymphocyte ratio in adenotonsillectomy and adenoidectomy PAIN (time frame: Postoperative 6 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2018.