Inflammatory Biomarkers as Predictors of PONV Following Pediatric Orchiopexy

September 8, 2025 updated by: Elif Sule Ozdemir, Diskapi Yildirim Beyazit Education and Research Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children aged 1-8 years with ASA physical status I-II who are scheduled to undergo elective orchiopexy under general anaesthesia

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 6 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 6 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2025

Primary Completion (Estimated)

March 13, 2026

Study Completion (Estimated)

March 27, 2026

Study Registration Dates

First Submitted

August 22, 2025

First Submitted That Met QC Criteria

August 22, 2025

First Posted (Estimated)

August 29, 2025

Study Record Updates

Last Update Posted (Estimated)

September 9, 2025

Last Update Submitted That Met QC Criteria

September 8, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AEŞH-EK-2025-205

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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