Comparing sevoflurane and intravenous anesthesia for hypospadias repair
Emergence Delirium in Pediatric Age Group: Comparison Between Sevoflurane and Intravenous Anesthesia in Hypospadias Repair: A Randomized Clinical Trial
This study tests whether using sevoflurane or intravenous anesthesia helps reduce agitation in young children recovering from hypospadias repair surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 1 Year to 8 Years |
| Sex | All |
| Sponsor | Benha University Academic / other |
| Locations | 1 site (Banha) |
| Trial ID | NCT06396468 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of sevoflurane versus total intravenous anesthesia (TIVA) using propofol and fentanyl on emergence agitation in children undergoing hypospadias repair. It aims to understand the incidence of emergence delirium associated with different anesthesia methods and their recovery profiles. The study includes children aged 1 to 8 years who are classified as ASA physical status I and II. By analyzing the outcomes, the research seeks to identify the optimal anesthesia approach for minimizing postoperative agitation.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 1 to 8 years scheduled for hypospadias repair with ASA physical status I or II.
Not a fit: Patients with active airway disease, sleep apnea, developmental delays, or other significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery experiences for pediatric patients undergoing hypospadias repair by reducing the incidence of emergence agitation.
How similar studies have performed: Previous studies have shown varying success with different anesthesia approaches in pediatric populations, but this specific comparison of sevoflurane and TIVA in the context of hypospadias repair is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ages 1 to 8 years * American society of anesthesiologists (ASA) physical status I and II, scheduled for hypospadias repair Exclusion Criteria: * children with a history of active airway disease, * sleep apnoea, developmental delay, * psychological, * neurological disorder, * cardiovascular abnormality or requirement of post-operative ventilation, * hepatic impairment, and renal insufficiency, with active upper respiratory tract infection
Where this trial is running
Banha
- Benha University — Banha, Egypt (Recruiting)
Study contacts
- Principal investigator: Ramy Saleh, MD — Anesthesia and surgical ICU department, Faculty of Medicine, Benha University, Egypt
- Study coordinator: Ramy Saleh, MD
- Email: ramymousa455@gmail.com
- Phone: 01024020922
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.