Inflammatory Biomarkers as Predictors of PONV Following Pediatric Orchiopexy

NCT07148063 | Recruiting

• 1 other identifier: AEŞH-EK-2025-205
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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, 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.

Conditions

Pediatric Anesthesia; Postoperative Nausea and Vomiting (PONV); Inflammatory Biomarkers

Keywords

Pediatric anesthesia; Orchiopexy; Postoperative Nausea and Vomiting (PONV); Inflammatory biomarkers

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 6 hours postoperatively

Secondary Outcomes (1)

• Need for Antiemetic Treatment

  Within 6 hours postoperatively

Interventions

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.

Eligibility Criteria

• Age: 1 Year - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Diskapi Yildirim Beyazit Education and Research Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Altındağ, Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Central Study Contacts

Elif Şule Özdemir Sezgi

CONTACT

00905059209638; elifsule-91@hotmail.com

Aslı Dönmez

CONTACT

00905322256473; aslidonmez@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal İnvestigator

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 29, 2025
• Study Start: September 8, 2025
• Primary Completion: March 13, 2026
• Study Completion: March 27, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

TU (1)