Pediatric AnesthesiaNCT07148063
Inflammatory Biomarkers as Predictors of PONV Following Pediatric Orchiopexy
An observational study of Pediatric Anesthesia and Postoperative Nausea and Vomiting (PONV), run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Orchiopexy is a common surgical procedure for the treatment of cryptorchidism in the pediatric population, with a high incidence of postoperative nausea and vomiting (PONV). Recent evidence suggests that systemic inflammation may contribute to PONV pathogenesis, and preoperative inflammatory biomarkers such as NLR… Read more about this study
- Who is it for?
- Ages 1 year to 8 years
- Conditions the study is for
- Pediatric Anesthesia, Postoperative Nausea and Vomiting (PONV), Inflammatory Biomarkers
- What is being tested?
- Measurement of Preoperative Inflammatory Biomarkers
- How many people
- 170 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Sep 2025to 27 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 year to 8 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 1-8 years with ASA physical status I-II who are scheduled to undergo elective orchiopexy under general anaesthesia
Who may be able to join
- Patients aged between 1 and 8 years
- Patients with ASA physical status I-II
- Patients scheduled for elective orchiopexy
- Obtained written informed consent from parents/guardians
Who cannot join
- Patients younger than 1 year or older than 8 years
- Patients with ASA physical status III or higher
- Presence of acute infection signs
- History of previous nausea or vomiting
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Etlik City Hospital
Altındağ, Ankara
Elif Şule Özdemir Sezgi, M.D., 00905059209638, elifsule-91@hotmail.com
Aslı Dönmez, Professor, 00905322256473, aslidonmez@hotmail.com
About this study
Official title: Association of Preoperative Inflammatory Biomarkers With Postoperative Nausea and Vomiting in Children Undergoing Orchiopexy
Orchiopexy is a common surgical procedure for the treatment of cryptorchidism in the pediatric population, with a high incidence of postoperative nausea and vomiting (PONV).
Recent evidence suggests that systemic inflammation may contribute to PONV pathogenesis, and preoperative inflammatory biomarkers such as NLR, PLR, SII, MLR, and SIRI could serve as predictive indicators.
This prospective observational study aims to evaluate the relationship between these biomarkers and PONV incidence in children undergoing orchiopexy.
- Being tested
- Measurement of Preoperative Inflammatory Biomarkers
- Keywords
- Pediatric anesthesia, Orchiopexy, Postoperative Nausea and Vomiting (PONV), Inflammatory biomarkers
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of Preoperative Inflammatory BiomarkersOther
Blood samples will be collected preoperatively to measure inflammatory biomarkers, including neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), systemic immune-inflammation index, monocyte-to-lymphocyte ratio (MLR), and systemic inflammation response index. These values will be analysed in relation to the incidence of postoperative nausea and vomiting within the first 6 hours after pediatric orchiopexy. No experimental drug or device will be administered as part of the study; all procedures will be conducted within the scope of standard perioperative care.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Nausea and Vomiting (PONV)
PONV will be assessed using a standardized nausea-vomiting scoring system by an anesthesiologist blinded to biomarker results.
Measured: Within 6 hours postoperatively
Secondary outcomes (1)
Need for Antiemetic Treatment
The number of patients who receive at least one dose of rescue antiemetic medication will be recorded within the first 6 hours after surgery.
Measured: Within 6 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start8 Sep 2025
- Primary completion13 Mar 2026 (estimated)
- Study completion27 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric AnesthesiaStudies of the same condition, open and under way.
- 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
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Elif Sule Ozdemir, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148063
- Sponsor's protocol ID
- AEŞH-EK-2025-205
- Status last verified
- Sep 2025
- First submitted
- 22 Aug 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Preoperative Inflammatory Biomarkers With Postoperative Nausea and Vomiting in Children Undergoing Orchiopexy
- ClinicalTrials.gov ID
- NCT07148063
- Acronym / sponsor ID
- AEŞH-EK-2025-205
- Keywords
- Pediatric anesthesia, Orchiopexy, Postoperative Nausea and Vomiting (PONV), Inflammatory biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 13 Mar 2026 (estimated)
- Study completion
- 27 Mar 2026 (estimated)
- First posted
- 29 Aug 2025 (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.
Orchiopexy is a common surgical procedure for the treatment of cryptorchidism in the pediatric population, with a high incidence of postoperative nausea and vomiting (PONV).
Recent evidence suggests that systemic inflammation may contribute to PONV pathogenesis, and preoperative inflammatory biomarkers such as NLR, PLR, SII, MLR, and SIRI could serve as predictive indicators.
This prospective observational study aims to evaluate the relationship between these biomarkers and PONV incidence in children undergoing orchiopexy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 1-8 years with ASA physical status I-II who are scheduled to undergo elective orchiopexy under general anaesthesia
Key inclusion criteria (4 listed)
- Patients aged between 1 and 8 years
- Patients with ASA physical status I-II
- Patients scheduled for elective orchiopexy
- Obtained written informed consent from parents/guardians
Key exclusion criteria (4 listed)
- Patients younger than 1 year or older than 8 years
- Patients with ASA physical status III or higher
- Presence of acute infection signs
- History of previous nausea or vomiting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of Preoperative Inflammatory BiomarkersBlood samples will be collected preoperatively to measure inflammatory biomarkers, including neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), systemic immune-inflammation index, monocyte-to-lymphocyte ratio (MLR), and systemic inflammation response index. These values will be analysed in relation to the incidence of postoperative nausea and vomiting within the first 6 hours after pediatric orchiopexy. No experimental drug or device will be administered as part of the study; all procedures will be conducted within the scope of standard perioperative care. | Other | – |
Primary outcome
Incidence of Postoperative Nausea and Vomiting (PONV)
Time frame: Within 6 hours postoperatively
PONV will be assessed using a standardized nausea-vomiting scoring system by an anesthesiologist blinded to biomarker results.
1 secondary outcome
Need for Antiemetic Treatment
Time frame: Within 6 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
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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.
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 Pediatric Anesthesia and Postoperative Nausea and Vomiting (PONV), run by Diskapi Yildirim Beyazit Education and Research Hospital 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 4 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: looking for participants now, as of the sponsor's last update on 9 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elif Şule Özdemir Sezgi (00905059209638, elifsule-91@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Nausea and Vomiting (PONV) (time frame: Within 6 hours postoperatively). 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 9 Sep 2025.