Spinal and General Anesthesia in Neonates Undergoing Herniorrhaphy

General Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06352606
• Other study ID #: 36264PR558/2/24
• Status: Recruiting
• Phase: N/A
• Start date: April 6, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: April 2024
• Source: Tanta University
• Contact: Mohammed S Elsharkawy, MD
• Phone: 00201148207870
• Email: mselsharkawy[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 1 Month

Eligibility

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).

Related Conditions & MeSH terms

• General Anesthesia
• Inguinal Herniorrhaphy
• Neonates
• Spinal Anesthesia

Intervention

Diagnostic Test:
• 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.
• 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.

Locations

Country	Name	City	State
Egypt	Tanta University Hospitals	Tanta	ElGharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate	Heart rate will be recorded at post-anesthesia care unit.	Immediately postoperatively at post-anesthesia care unit
Secondary	Heart rate	Heart rate will be recorded at baseline, every 10 min intraoperatively and every 30 min in post-anesthesia care unit.	Till two hours postoperatively
Secondary	Mean arterial blood pressure	Mean arterial blood pressure will be recorded at baseline, every 10 min intraoperatively and every 30 min in post-anesthesia care unit.	Till two hours postoperatively
Secondary	Incidence of bradycardia	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.	24 hours postoperative
Secondary	Incidence of hypotension	Hypotension will be assessed	24 hours postoperative
Secondary	Incidence of postoperative apnea	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.	24 hour postoperatively
Secondary	The duration of surgery	The duration of surgery will be assessed from the start of surgery till the end of surgery.	Till the end of surgery
Secondary	Need for postoperative O2 supplementation	Oxygen saturation will be recorded at baseline, every 10min intraoperatively and every 30 min in post-anesthesia care unit (PACU).	Till two hours postoperatively
Secondary	Hospital stays	Hospital stays will be assessed from admission till discharge from hospital	28 days postoperative