Spinal AnesthesiaNCT06352606
Spinal and General Anesthesia in Neonates Undergoing Herniorrhaphy
A study testing Spinal anesthesia and General anesthesia in people with Spinal Anesthesia and General Anesthesia, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to compare spinal and general anesthesia in neonates undergoing herniorrhaphy. Read more about this study
- Who is it for?
- Ages 1 day to 1 month
- Conditions the study is for
- Spinal Anesthesia, General Anesthesia, Neonates
- What is being tested?
- Spinal anesthesia and General anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Apr 2024to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates either full term or preterm.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I-II
- Undergoing unilateral or bilateral inguinal herniorrhaphy.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University Hospitals
Tanta, ElGharbia, 31527
Mohammed S Elsharkawy, MD, 00201148207870, mselsharkawy@med.tanta.edu.eg
Ahmed E Abo ElKheir, MD
About this study
Official title: Comparison Between Spinal and General Anesthesia in Neonates Undergoing Herniorrhaphy: A Randomized Controlled Trial
The aim of this study is to compare spinal and general anesthesia in neonates undergoing herniorrhaphy.
Read the 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
- Being tested
- Spinal anesthesia, General anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anesthesiaDiagnostic 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 anesthesiaDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Heart rate will be recorded at post-anesthesia care unit.
Measured: Immediately postoperatively at post-anesthesia care unit
Secondary outcomes (8)
Heart rate
Heart rate will be recorded at baseline, every 10 min intraoperatively and every 30 min in post-anesthesia care unit.
Measured: Till two hours postoperatively
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.
Measured: Till two hours postoperatively
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.
Measured: 24 hours postoperative
Incidence of hypotension
Hypotension will be assessed
Measured: 24 hours postoperative
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.
Measured: 24 hour postoperatively
The duration of surgery
The duration of surgery will be assessed from the start of surgery till the end of surgery.
Measured: Till the end of surgery
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).
Measured: Till two hours postoperatively
Hospital stays
Hospital stays will be assessed from admission till discharge from hospital
Measured: 28 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start6 Apr 2024
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Said ElSharkawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352606
- Sponsor's protocol ID
- 36264PR558/2/24
- Status last verified
- Apr 2024
- First submitted
- 2 Apr 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Spinal and General Anesthesia in Neonates Undergoing Herniorrhaphy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06352606
- Acronym / sponsor ID
- 36264PR558/2/24
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 6 Apr 2024 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Anesthesia | Experimental | Diagnostic Test: Spinal anesthesiaOxygen 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 | Active comparator | Diagnostic Test: General anesthesiaPatients 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. |
Who may qualify
- Ages
- 1 day to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Neonates either full term or preterm.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I-II
- Undergoing unilateral or bilateral inguinal herniorrhaphy.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal anesthesiaOxygen 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 anesthesiaPatients 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 |
Primary outcome
Heart rate
Time frame: Immediately postoperatively at post-anesthesia care unit
Heart rate will be recorded at post-anesthesia care unit.
8 secondary outcomes
Heart rate
Time frame: Till two hours postoperatively
Mean arterial blood pressure
Time frame: Till two hours postoperatively
Incidence of bradycardia
Time frame: 24 hours postoperative
Incidence of hypotension
Time frame: 24 hours postoperative
Incidence of postoperative apnea
Time frame: 24 hour postoperatively
The duration of surgery
Time frame: Till the end of surgery
Need for postoperative O2 supplementation
Time frame: Till two hours postoperatively
Hospital stays
Time frame: 28 days postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal anesthesia and General anesthesia in people with Spinal Anesthesia and General Anesthesia, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed S Elsharkawy, MD (00201148207870, mselsharkawy@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: Immediately postoperatively at post-anesthesia care unit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.