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NCT Number: NCT07148063

Inflammatory Biomarkers as Predictors of PONV Following Pediatric 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.

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Key information

Conditions

Pediatric Anesthesia Inflammatory Biomarkers Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Postoperative Nausea and Vomiting (PONV) Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

1 year–8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Measurement of Preoperative Inflammatory Biomarkers

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Need for Antiemetic Treatment

    Time frame: Within 6 hours postoperatively

    The number of patients who receive at least one dose of rescue antiemetic medication will be recorded within the first 6 hours after surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Aslı Dönmez

CONTACT

[email protected]

00905322256473

Elif Şule Özdemir Sezgi

CONTACT

[email protected]

00905059209638

Sponsors and collaborators

Lead sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Other Gov

Registry information

Official study title

Association of Preoperative Inflammatory Biomarkers With Postoperative Nausea and Vomiting in Children Undergoing Orchiopexy

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 29, 2025
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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