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Spinal and General Anesthesia in Neonates Undergoing Herniorrhaphy

Not Applicable
Recruiting
Conditions
Spinal Anesthesia
General Anesthesia
Neonates
Inguinal Herniorrhaphy
Interventions
Diagnostic Test: General anesthesia
Diagnostic 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
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).

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
General AnesthesiaGeneral anesthesiaPatients 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 AnesthesiaSpinal anesthesiaOxygen 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
NameTimeMethod
Heart rateImmediately postoperatively at post-anesthesia care unit

Heart rate will be recorded at post-anesthesia care unit.

Secondary Outcome Measures
NameTimeMethod
Heart rateTill 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 surgeryTill the end of surgery

The duration of surgery will be assessed from the start of surgery till the end of surgery.

Incidence of hypotension24 hours postoperative

Hypotension will be assessed

Mean arterial blood pressureTill 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 bradycardia24 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 apnea24 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 supplementationTill two hours postoperatively

Oxygen saturation will be recorded at baseline, every 10min intraoperatively and every 30 min in post-anesthesia care unit (PACU).

Hospital stays28 days postoperative

Hospital stays will be assessed from admission till discharge from hospital

Trial Locations

Locations (1)

Tanta University Hospitals

🇪🇬

Tanta, ElGharbia, Egypt

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