Spinal and General Anesthesia in Neonates Undergoing Herniorrhaphy

NCT ID: NCT06352606

Last Updated: 2024-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-06

Study Completion Date

2024-09-01

Brief Summary

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

Detailed Description

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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

Conditions

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Spinal Anesthesia General Anesthesia Neonates Inguinal Herniorrhaphy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Spinal anesthesia

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

General anesthesia

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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).
Minimum Eligible Age

1 Day

Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Said ElSharkawy

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta University Hospitals

Tanta, ElGharbia, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohammed S Elsharkawy, MD

Role: CONTACT

00201148207870

Facility Contacts

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Mohammed S Elsharkawy, MD

Role: primary

00201148207870

Other Identifiers

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36264PR558/2/24

Identifier Type: -

Identifier Source: org_study_id

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