Inflammatory Biomarkers as Predictors of PONV Following Pediatric Orchiopexy

NCT ID: NCT07148063

Last Updated: 2025-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-08

Study Completion Date

2026-03-27

Brief Summary

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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.

Detailed Description

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Conditions

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Pediatric Anesthesia Postoperative Nausea and Vomiting (PONV) Inflammatory Biomarkers

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Measurement of Preoperative Inflammatory Biomarkers

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

1 Year

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diskapi Yildirim Beyazit Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Elif Sule Ozdemir

Principal İnvestigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ankara Etlik City Hospital

Altındağ, Ankara, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Elif Şule Özdemir Sezgi

Role: CONTACT

00905059209638

Aslı Dönmez

Role: CONTACT

00905322256473

Facility Contacts

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Elif Şule Özdemir Sezgi, M.D.

Role: primary

00905059209638

Aslı Dönmez, Professor

Role: backup

00905322256473

Other Identifiers

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AEŞH-EK-2025-205

Identifier Type: -

Identifier Source: org_study_id

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