Optic Nerve Sheath DiameterNCT06187714
Effect of Caudal Block Injection Rate on Optic Nerve Sheath Diameter in Pediatric Surgeries
An observational study of Optic Nerve Sheath Diameter and Caudal Block, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial summary
Our prospective observational study will include patients between the ages of 1-7 years, ASA 1-2, who will undergo elective surgery under general anesthesia, whose consent was obtained by their parents for the procedure to be performed. Optic nerve sheath diameter of the patients will be measured and recorded. Read more about this study
- Who is it for?
- Ages 1 year to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Optic Nerve Sheath Diameter, Caudal Block
- What is being tested?
- caudal block rate
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jul 2023to 5 Feb 2024
- Phase
- Observational
- 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 year to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: pediatric patients aged 1-7 years for caudal block
Who may be able to join
- Patients aged 1-7 years, ASA 1-2, who will undergo elective surgery under general anesthesia, in whom consent has been obtained for the procedure to be performed
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof. Dr. Cemil Tascioglu City Hospital
Istanbul, Sisli, 34400
About this study
Our prospective observational study will include patients between the ages of 1-7 years, ASA 1-2, who will undergo elective surgery under general anesthesia, whose consent was obtained by their parents for the procedure to be performed. Optic nerve sheath diameter of the patients will be measured and recorded.
Read the detailed description
The study will be conducted with patients who will undergo elective surgery and caudal block will be applied between 05.07.2023-05.09.2023 in the Anesthesiology and Reanimation Clinic of Prof. Dr. Cemil Taşçıoğlu City Hospital after Ethics Committee approval and written and verbal consent of the patients. Our prospective observational study will include patients between the ages of 1-7 years, ASA 1-2, who will undergo elective surgery under general anesthesia, whose consent was obtained by their parents for the procedure to be performed. Gender, age, weight, height, body mass index (BMI), ASA (American Society of Anesthesiology) score and medical history of the patients will be recorded. Injection times of pediatric patients who underwent caudal block with 0.125% bupivacaine at a dose of 0.8 ml/kg using a 22 gauge caudal needle will be noted. Optic nerve sheath diameter of the patients will be measured and recorded. Intraoperative hemodynamic parameters, postoperative complications (nausea, vomiting, urinary retention) will also be noted.
- Conditions
- Optic Nerve Sheath Diameter, Caudal Block
- Being tested
- caudal block rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caudal block rateProcedure or surgery
optic nerve sheath diameter measurement according to caudal block rate
| Study group | Role | What they receive |
|---|---|---|
| 0.25ml/sec | Not described Receives: Procedure: caudal block rate | |
| 0.5ml/sec dose | Not described Receives: Procedure: caudal block rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
optic nerve sheath diameter measurement
optic nerve sheath diameter
Measured: 1st minute after caudal block
Secondary outcomes (1)
optic nerve sheath diameter measurement
optic nerve sheath diameter
Measured: 10th minute after caudal block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start5 Jul 2023
- Primary completion5 Oct 2023
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic Nerve Sheath DiameterStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasim Onur Karaoglu, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187714
- Sponsor's protocol ID
- 681429
- Status last verified
- Aug 2024
- First submitted
- 17 Dec 2023
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Caudal Block Injection Rate on Optic Nerve Sheath Diameter in Pediatric Surgeries
- ClinicalTrials.gov ID
- NCT06187714
- Acronym / sponsor ID
- 681429
- Conditions
- Optic Nerve Sheath Diameter, Caudal Block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 5 Oct 2023 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 3 Jan 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.
Our prospective observational study will include patients between the ages of 1-7 years, ASA 1-2, who will undergo elective surgery under general anesthesia, whose consent was obtained by their parents for the procedure to be performed. Optic nerve sheath diameter of the patients will be measured and recorded.
Detailed description
The study will be conducted with patients who will undergo elective surgery and caudal block will be applied between 05.07.2023-05.09.2023 in the Anesthesiology and Reanimation Clinic of Prof. Dr. Cemil Taşçıoğlu City Hospital after Ethics Committee approval and written and verbal consent of the patients. Our prospective observational study will include patients between the ages of 1-7 years, ASA 1-2, who will undergo elective surgery under general anesthesia, whose consent was obtained by their parents for the procedure to be performed. Gender, age, weight, height, body mass index (BMI), ASA (American Society of Anesthesiology) score and medical history of the patients will be recorded. Injection times of pediatric patients who underwent caudal block with 0.125% bupivacaine at a dose of 0.8 ml/kg using a 22 gauge caudal needle will be noted. Optic nerve sheath diameter of the patients will be measured and recorded. Intraoperative hemodynamic parameters, postoperative complications (nausea, vomiting, urinary retention) will also be noted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.25ml/sec | – | Procedure: caudal block rate |
| 0.5ml/sec dose | – | Procedure: caudal block rate |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- pediatric patients aged 1-7 years for caudal block
Key inclusion criteria (1 listed)
- Patients aged 1-7 years, ASA 1-2, who will undergo elective surgery under general anesthesia, in whom consent has been obtained for the procedure to be performed
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| caudal block rateoptic nerve sheath diameter measurement according to caudal block rate | Procedure or surgery | 0.25ml/sec, 0.5ml/sec dose |
Primary outcome
optic nerve sheath diameter measurement
Time frame: 1st minute after caudal block
optic nerve sheath diameter
1 secondary outcome
optic nerve sheath diameter measurement
Time frame: 10th minute after caudal block
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 21 Aug 2024.
- Individual participant dataSharing planned: Yes
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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?
An observational study of Optic Nerve Sheath Diameter and Caudal Block, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 21 Aug 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 Turkey (Türkiye). 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?
optic nerve sheath diameter measurement (time frame: 1st minute after caudal block). 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 21 Aug 2024.