Comparing spinal and general anesthesia for neonates having hernia surgery
Comparison Between Spinal and General Anesthesia in Neonates Undergoing Herniorrhaphy: A Randomized Controlled Trial
This study is testing whether spinal anesthesia or general anesthesia is safer and more effective for newborns having hernia surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 1 Day to 1 Month |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, ElGharbia) |
| Trial ID | NCT06352606 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness and safety of spinal anesthesia versus general anesthesia in neonates undergoing inguinal herniorrhaphy. It will evaluate postoperative outcomes, focusing on respiratory morbidity and oxygen desaturation rates. The study includes both full-term and preterm neonates classified as ASA physical status I-II. By analyzing these two anesthesia methods, the research seeks to determine which approach offers better outcomes for this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are neonates, both full-term and preterm, who are undergoing unilateral or bilateral inguinal herniorrhaphy and are classified as ASA physical status I-II.
Not a fit: Patients with obstructed hernias, significant chronic lung disease, symptomatic congenital heart disease, or symptomatic central nervous system disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved anesthesia practices for neonates, reducing postoperative complications and enhancing recovery.
How similar studies have performed: Previous studies have shown promising results with spinal anesthesia in infants, indicating a potential advantage over general anesthesia, although this specific comparison is less commonly explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Neonates either full term or preterm. * Both sexes. * American Society of Anesthesiologists (ASA) physical status I-II * Undergoing unilateral or bilateral inguinal herniorrhaphy. Exclusion Criteria: * Obstructed hernia. * Neonates with significant chronic lung disease (e.g., disease associated with hypoxemia in room air or chronic hypercapnia). * Symptomatic congenital heart disease (e.g., cyanosis or congestive heart failure). * Symptomatic central nervous system disease (e.g., seizures).
Where this trial is running
Tanta, ElGharbia
- Tanta University Hospitals — Tanta, ElGharbia, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohammed S Elsharkawy, MD
- Email: mselsharkawy@med.tanta.edu.eg
- Phone: 00201148207870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.