Spinal and General Anesthesia in Neonates Undergoing Herniorrhaphy

NCT06352606 | Recruiting

• 1 other identifier: 36264PR558/2/24
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Spinal Anesthesia; General Anesthesia; Neonates; Inguinal Herniorrhaphy

Outcome Measures

Primary Outcomes (1)

• Heart rate

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

  Immediately postoperatively at post-anesthesia care unit

Secondary Outcomes (8)

• Heart rate

  Till two hours postoperatively

• Mean arterial blood pressure

  Till two hours postoperatively

• Incidence of bradycardia

  24 hours postoperative

• Incidence of hypotension

  24 hours postoperative

• Incidence of postoperative apnea

  24 hour postoperatively

Study Arms (2)

Spinal Anesthesia

EXPERIMENTAL

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 Test: Spinal anesthesia

General Anesthesia

ACTIVE COMPARATOR

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.

Diagnostic Test: General anesthesia

Interventions

Spinal anesthesia DIAGNOSTIC_TEST

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

Spinal Anesthesia

General anesthesia DIAGNOSTIC_TEST

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.

General Anesthesia

Eligibility Criteria

• Age: 1 Day - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neonates either full term or preterm.
• Both sexes.
• American Society of Anesthesiologists (ASA) physical status I-II
• Undergoing unilateral or bilateral inguinal herniorrhaphy.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, ElGharbia, 31527, Egypt

RECRUITING

Central Study Contacts

Mohammed S Elsharkawy, MD

CONTACT

00201148207870; mselsharkawy@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: April 6, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)