NCT07511764

Comparison of Laryngeal Mask Airway Versus Endotracheal Intubation in Pediatric Laparoscopic Inguinal Hernia Repair: A Multicenter, Prospective, Randomized Controlled Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 266 (estimated)
• Sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 10 Years
• Healthy volunteers: Not accepted

Summary

Inguinal hernia is one of the most common conditions requiring surgical intervention in childhood, with a reported lifetime prevalence of 1-4%. With the increasing use of minimally invasive techniques such as PIRS (Percutaneous Internal Ring Suturing) among laparoscopic surgical procedures, perioperative anesthesia and airway management have become a critical area of clinical decision-making. The traditional approach in pediatric laparoscopic surgery is endotracheal intubation (ETT). Although ETT provides reliable airway control, it carries certain disadvantages. In contrast, the laryngeal mask airway (LMA) is less invasive and is associated with faster recovery. Systematic reviews and meta-analyses conducted in recent years have shown that the LMA may be safe for ventilation in pediatric laparoscopy, reduces peak airway pressure, and shortens recovery time. No well-designed, multicenter study with an adequate sample size comparing the LMA and ETT in pediatric laparoscopic inguinal hernia surgery has yet been conducted. This gap limits evidence-based decision-making in a clinical setting that directly impacts practice. Therefore, the aim of this study is to compare LMA and ETT in pediatric laparoscopic inguinal hernia repair. In this regard, the study is unique and necessary from both clinical and academic perspectives for determining the optimal airway strategy in pediatric laparoscopy.

Detailed description

This study is designed as a multicenter, prospective, randomized controlled clinical trial to compare laryngeal mask airway (LMA) and endotracheal intubation (ETT) in pediatric laparoscopic inguinal hernia repair. 266 patients will be included in the study. Patients will be randomly assigned to two groups using a simple randomization method: 1) those who received general anesthesia with LMA (n=133), 2) those who received general anesthesia with endotracheal intubation. The study population will consist of pediatric patients aged 1-10 years who are scheduled for elective laparoscopic inguinal hernia repair and are classified as American Society of Anesthesiologists (ASA) I-II. Inclusion criteria are: being aged 1-10 years, having a scheduled laparoscopic inguinal hernia repair, being classified as ASA I-II, and having given informed parental consent. Exclusion criteria include: obesity (body weight \>95th percentile), symptomatic gastroesophageal reflux, conditions with a high risk of aspiration, upper airway anomalies, history of difficult intubation, acute respiratory tract infection, emergency surgical indication, need for conversion from laparoscopy to open surgery, and the presence of additional systemic risks such as immunodeficiency/malignancy. Anesthesia protocols will be standardized across all centers. Demographic and clinical characteristics of patients, such as age, ASA, presence of comorbidities, medications used, and history of previous surgery, will be recorded. Primary outcome measures are: oxygen saturation (SpO₂), end-tidal carbon dioxide (EtCO₂) level, and airway safety (complications such as laryngospasm, bronchospasm, desaturation, and aspiration). Secondary outcome measures include parameters such as peak airway pressure (PAP), mean airway pressure, anesthesia duration, muscle relaxant requirement, recovery time, PACU dwell time, postoperative airway signs (cough, stridor), and the need for conversion from LMA to ETT.

Conditions

• Inguinal Hernia Repair

Interventions

Type	Name	Description
PROCEDURE	General Aneasthesia	Laryngeal mask airway (LMA) or endotracheal intubation (ETT) in pediatric laparoscopic inguinal hernia repair

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-04-01
• Completion: 2026-06-01
• First posted: 2026-04-06
• Last updated: 2026-04-06

Locations

1 site across 1 country: Turkey (Türkiye)