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Clinical Trials/NCT06352606
NCT06352606
Recruiting
Not Applicable

Comparison Between Spinal and General Anesthesia in Neonates Undergoing Herniorrhaphy: A Randomized Controlled Trial

Tanta University1 site in 1 country74 target enrollmentApril 6, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Anesthesia
Sponsor
Tanta University
Enrollment
74
Locations
1
Primary Endpoint
Heart rate
Status
Recruiting
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
April 6, 2024
End Date
September 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohammed Said ElSharkawy

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Tanta University

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Heart rate

Time Frame: Immediately postoperatively at post-anesthesia care unit

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

Secondary Outcomes

  • Heart rate(Till two hours postoperatively)
  • The duration of surgery(Till the end of surgery)
  • Incidence of hypotension(24 hours postoperative)
  • Mean arterial blood pressure(Till two hours postoperatively)
  • Incidence of bradycardia(24 hours postoperative)
  • Incidence of postoperative apnea(24 hour postoperatively)
  • Need for postoperative O2 supplementation(Till two hours postoperatively)
  • Hospital stays(28 days postoperative)

Study Sites (1)

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