Stress ResponseNCT06909396
Stress Response and Hemodynamic Changes Associated With Intrathecal Anesthesia Versus Caudal Epidural Anesthesia in Infants Undergoing Laparoscopic Inguinal Herniorrhaphy
A study testing General anesthesia, Intrathecal Anesthesia and Caudal block in people with Stress Response and Hemodynamic Changes, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this work was to assess stress response and hemodynamic changes associated with intrathecal anesthesia versus caudal epidural anesthesia in infants undergoing laparoscopic inguinal herniorrhaphy. Read more about this study
- Who is it for?
- Ages 1 month to 1 year
- Conditions the study is for
- Stress Response, Hemodynamic Changes, Intrathecal Anesthesia
- What is being tested?
- General anesthesia, Intrathecal Anesthesia and Caudal block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 20 Jan 2025
- 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 month to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age from full term one month to one year.
- Both sexes.
- Patients with clinical criteria of laparoscopic inguinal herniorrhaphy.
Who cannot join
- Refusal of patients' parents.
- Diseases of the central nervous system.
- Patients with metabolic and coagulation defects.
- Pre-term infant.
- Infection at the site of injection.
- Congenital anomaly in vertebral column.
- Patient treated with corticosteroids.
- Patients with respiratory dysfunction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stress Response and Hemodynamic Changes Associated With Intrathecal Anesthesia Versus Caudal Epidural Anesthesia in Infants Undergoing Laparoscopic Inguinal Herniorrhaphy: Prospective Randomized Control Study
The aim of this work was to assess stress response and hemodynamic changes associated with intrathecal anesthesia versus caudal epidural anesthesia in infants undergoing laparoscopic inguinal herniorrhaphy.
Read the detailed description
Inguinal hernia repair is the most frequent surgical procedure in early childhood. Various regional anesthetic techniques have been employed to provide optimum intraoperative and postoperative pain control after this procedure.
Introduced decades ago, the use of intrathecal (spinal) anesthesia and caudal block in procedures for different types of laparoscopic abdominal surgery is safe and efficient.
Caudal block is now frequently used in intraoperative and postoperative analgesia for pediatric surgery. In infants and children, central neuraxial block is an important modality for acute postoperative analgesia in addition to combined anesthesia, the goals of postoperative analgesia in children are pain eradication, expedient recovery to daily activities, and prevention of progression of acute postsurgical pain to chronic pain or hyperalgesia
- Conditions
- Stress Response, Hemodynamic Changes, Intrathecal Anesthesia, Caudal Epidural Anesthesia, Infants, Laparoscopic Inguinal Herniorrhaphy
- Being tested
- General anesthesia, Intrathecal Anesthesia, Caudal block
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anesthesiaDrug
Patients received general anesthesia
Intrathecal AnesthesiaDrug
Patients received intrathecal Anesthesia
Caudal blockDrug
Patients received caudal epidural anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Patients received general anesthesia. Receives: Drug: General anesthesia |
| Intrathecal group | Experimental | Patients received intrathecal anesthesia. Receives: Drug: Intrathecal Anesthesia |
| Caudal block group | Experimental | Patients received caudal epidural anesthesia. Receives: Drug: Caudal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum glucose level
Serum glucose level was recorded pre-operative and just postoperative and 6, 12, and 24h postoperatively.
Measured: 24 hours postoperatively
Secondary outcomes (5)
Serum cortisol level
Serum cortisol level was recorded pre-operative and just postoperative and 6, 12, and 24h postoperatively.
Measured: 24 hours postoperatively
Heart rate
Heart rate was recorded at baseline, after induction, then every 15 minutes till the end of surgery.
Measured: Till the end of surgery (Up to 1 hour)
Mean arterial pressure
Mean arterial pressure was recorded at baseline, after induction, then every 15 minutes till the end of surgery.
Measured: Till the end of surgery (Up to 1 hour)
Intraoperative anesthetic consumption
Intraoperative anesthetic consumption of sevoflurane was recorded.
Measured: Intraoperatively
Total analgesics consumption
Intravenous Tramadol 1 mg/kg is administered intravenously in the event that the Face, Legs, Activity, Cry, Consolability (FLACC) score exceeds 4 within the first 24 hours following surgery.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start1 Jun 2023
- Primary completion20 Jan 2025
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress ResponseStudies 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manar Mohammed Ismail, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909396
- Sponsor's protocol ID
- 35680/8/22
- Status last verified
- Mar 2025
- First submitted
- 27 Mar 2025
- Last updated
- 3 Apr 2025
- 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 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Response and Hemodynamic Changes Associated With Intrathecal Anesthesia Versus Caudal Epidural Anesthesia in Infants Undergoing Laparoscopic Inguinal Herniorrhaphy: Prospective Randomized Control Study
- ClinicalTrials.gov ID
- NCT06909396
- Acronym / sponsor ID
- 35680/8/22
- Conditions
- Stress Response, Hemodynamic Changes, Intrathecal Anesthesia, Caudal Epidural Anesthesia, Infants, Laparoscopic Inguinal Herniorrhaphy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 3 Apr 2025 (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 work was to assess stress response and hemodynamic changes associated with intrathecal anesthesia versus caudal epidural anesthesia in infants undergoing laparoscopic inguinal herniorrhaphy.
Detailed description
Inguinal hernia repair is the most frequent surgical procedure in early childhood. Various regional anesthetic techniques have been employed to provide optimum intraoperative and postoperative pain control after this procedure.
Introduced decades ago, the use of intrathecal (spinal) anesthesia and caudal block in procedures for different types of laparoscopic abdominal surgery is safe and efficient.
Caudal block is now frequently used in intraoperative and postoperative analgesia for pediatric surgery. In infants and children, central neuraxial block is an important modality for acute postoperative analgesia in addition to combined anesthesia, the goals of postoperative analgesia in children are pain eradication, expedient recovery to daily activities, and prevention of progression of acute postsurgical pain to chronic pain or hyperalgesia
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: General anesthesiaPatients received general anesthesia. |
| Intrathecal group | Experimental | Drug: Intrathecal AnesthesiaPatients received intrathecal anesthesia. |
| Caudal block group | Experimental | Drug: Caudal blockPatients received caudal epidural anesthesia. |
Who may qualify
- Ages
- 1 month to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age from full term one month to one year.
- Both sexes.
- Patients with clinical criteria of laparoscopic inguinal herniorrhaphy.
Key exclusion criteria (8 listed)
- Refusal of patients' parents.
- Diseases of the central nervous system.
- Patients with metabolic and coagulation defects.
- Pre-term infant.
- Infection at the site of injection.
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 |
|---|---|---|
| General anesthesiaPatients received general anesthesia | Drug | Control group |
| Intrathecal AnesthesiaPatients received intrathecal Anesthesia | Drug | Intrathecal group |
| Caudal blockPatients received caudal epidural anesthesia. | Drug | Caudal block group |
Primary outcome
Serum glucose level
Time frame: 24 hours postoperatively
Serum glucose level was recorded pre-operative and just postoperative and 6, 12, and 24h postoperatively.
5 secondary outcomes
Serum cortisol level
Time frame: 24 hours postoperatively
Heart rate
Time frame: Till the end of surgery (Up to 1 hour)
Mean arterial pressure
Time frame: Till the end of surgery (Up to 1 hour)
Intraoperative anesthetic consumption
Time frame: Intraoperatively
Total analgesics consumption
Time frame: 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General anesthesia, Intrathecal Anesthesia and Caudal block in people with Stress Response and Hemodynamic Changes, 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 3 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum glucose level (time frame: 24 hours postoperatively). 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 3 Apr 2025.