General Anesthesia, Inguinal Herniorrhaphy, Neonates, Spinal Anesthesia
Conditions
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
Interventions
DIAGNOSTIC_TESTSpinal 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.
DIAGNOSTIC_TESTGeneral 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.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 1 Months
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | Immediately postoperatively at post-anesthesia care unit | Heart rate will be recorded at post-anesthesia care unit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 hypotension | 24 hours postoperative | Hypotension will be assessed |
| 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. |
| 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 |
| 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. |
Countries
Egypt
Contacts
Primary ContactMohammed S Elsharkawy, MD
Outcome results
None listed