Spinal and General Anesthesia in Neonates Undergoing Herniorrhaphy

Tanta University

Status: Enrolling

Conditions: Neonates; Spinal Anesthesia; General Anesthesia; Inguinal Herniorrhaphy

Treatments: Diagnostic Test: Spinal anesthesia; Diagnostic Test: General anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT06352606

36264PR558/2/24

Details and patient eligibility

About

The aim of this study is to compare spinal and general anesthesia in neonates undergoing herniorrhaphy.

Full 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

Enrollment: 74 estimated patients

Sex: All

Ages: 1 day to 1 month old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Spinal Anesthesia

Experimental group

Description:

Oxygen supply will be done via nasal prong (2 L/min) when necessary. The local anesthetic used will be bupivacaine 0.6 mg/kg.

Treatment:

Diagnostic Test: Spinal anesthesia

General Anesthesia

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: General anesthesia