Spinal and General Anesthesia in Neonates Undergoing Herniorrhaphy
- Conditions
- Spinal AnesthesiaGeneral AnesthesiaNeonatesInguinal Herniorrhaphy
- Interventions
- Diagnostic Test: General anesthesiaDiagnostic Test: Spinal anesthesia
- Registration Number
- NCT06352606
- Lead Sponsor
- Tanta University
- Brief Summary
The aim of this study is to compare spinal and general anesthesia in neonates undergoing herniorrhaphy.
- Detailed Description
Spinal anesthesia (SA) is a fast, simple and cost-effective method that has been used for the performance of inguinal hernias since the beginning of the 20th century in adults.
One large observational study documented a low risk of post operative events with spinal anesthesia for inguinal hernia repair in infants . In addition, a randomized trial comparing reginal and general anesthesia in this population have not shown any significant differences in outcome. Spinal anesthesia reduces postoperative oxygen desaturation and respiratory morbidity when compared to general anesthesia (GA) in infants who underwent inguinal herniorrhaphy
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 74
- Neonates either full term or preterm.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I-II
- Undergoing unilateral or bilateral inguinal herniorrhaphy.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description General Anesthesia General anesthesia Patients will receive sevoflurane for induction and maintenance in an air/oxygen mixture along. Endotracheal tube will be inserted. No opioids or nitrous oxide was used intraoperatively. Spinal Anesthesia Spinal anesthesia Oxygen supply will be done via nasal prong (2 L/min) when necessary. The local anesthetic used will be bupivacaine 0.6 mg/kg.
- Primary Outcome Measures
Name Time Method Heart rate Immediately postoperatively at post-anesthesia care unit Heart rate will be recorded at post-anesthesia care unit.
- Secondary Outcome Measures
Name Time Method Heart rate Till two hours postoperatively Heart rate will be recorded at baseline, every 10 min intraoperatively and every 30 min in post-anesthesia care unit.
The duration of surgery Till the end of surgery The duration of surgery will be assessed from the start of surgery till the end of surgery.
Incidence of hypotension 24 hours postoperative Hypotension will be assessed
Mean arterial blood pressure Till two hours postoperatively Mean arterial blood pressure will be recorded at baseline, every 10 min intraoperatively and every 30 min in post-anesthesia care unit.
Incidence of bradycardia 24 hours postoperative Incidence of bradycardia will be measured, defined by decrease in basal heart rate by 20% and will be treated by I.V. atropine 0.02 mg/kg.
Incidence of postoperative apnea 24 hour postoperatively Apnea is defined as a pause in breathing for more than 15 s or more than 10 s if associated with oxygen saturation less than 80% or bradycardia (20% decrease in heart rate). Early apnea is defined as a priori as an apnea occurring within the first 30min postoperatively in the PACU, and late apnea is defined as an observed apnea occurring between 30 min and 12 hour postoperatively.
Need for postoperative O2 supplementation Till two hours postoperatively Oxygen saturation will be recorded at baseline, every 10min intraoperatively and every 30 min in post-anesthesia care unit (PACU).
Hospital stays 28 days postoperative Hospital stays will be assessed from admission till discharge from hospital
Trial Locations
- Locations (1)
Tanta University Hospitals
🇪🇬Tanta, ElGharbia, Egypt