Anesthesia, CaudalNCT04491032
Pediatric Caudal Injection Volume on Optic Nerve Sheath Diameter and Cerebral Oxygenation
A study testing Caudal anesthesia in people with Anesthesia, Caudal and Pediatrics, run by Aybike Onur Gönen at 1 site in Turkey (Türkiye).
Trial summary
Caudal anesthesia is a commonly used neuraxial anesthesia method for children. Injection of a certain volume of fluid into the epidural space for cauda anesthesia may push some cerebrospinal fluid towards the head, which may lead to mild increase of pressures inside the head. Read more about this study
- Who is it for?
- Ages 12 months to 8 years
- Conditions the study is for
- Anesthesia, Caudal, Pediatrics, Elevated Intracranial Pressure
- What is being tested?
- Caudal anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2019to 15 Mar 2022
- 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 12 months to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA class 1 or 2
- Scheduled for elective surgery suitable for caudal anesthesia
- Parental/guardian consent for caudal anesthesia and measurements obtained
- Closed fontanelles
Who cannot join
- Open fontanelle
- Parental/guardian refusal
- Previous intracranial or ocular pathology
- Coagulapathies
- Variations in gross and ultrasonographic sacral anatomy
- Block performence to end of surgery expected to last less than 30 minutes
Show all 9Show fewer
- Block volumes more than 30ml needed
- Laparoscopic surgery
- Need for long term analgesia with epidural catheter
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Cerrahpasa
Istanbul, 34098
About this study
Official title: The Effect of Caudal Epidural Injection Volume on Optic Nerve Sheath Diameter and Cerebral Oxygenation in Pediatric Cases
Caudal anesthesia is a commonly used neuraxial anesthesia method for children. Injection of a certain volume of fluid into the epidural space for cauda anesthesia may push some cerebrospinal fluid towards the head, which may lead to mild increase of pressures inside the head. Such mild changes are compensated well by healthy individuals and no clinical sequel is seen, however at-risk populations may be affected. We aim to see how different amounts of fluid injected into the epidural space may change two clinical parameters affected by intracranial pressure to determine if a lower volume is safer than a higher one.
Read the detailed description
Caudal epidural injection of local anesthetic solution is a common neuraxial anesthesia technique that provides excellent peri-operative analgesia in children. Unfused sacral hiatus allows for easy and safe access into the epidural space. Anatomically, injection of a certain volume of fluid over the dural sac inside the closed spinal canal can push the cerebrospinal fluid cranially. This push may lead to increased intracranial pressure. We will measure two findings affected by intracranial pressure (optic nerve sheath diameter and cerebral oxygenation) and compare the effects of two different volumes of caudal injections on these measures.
Children with closed fontanelles and scheduled to undergo elective surgery, for which caudal anesthesia is an effective method for peri-operative analgesia, will be recruited for this study. Injection volume will be determined depending on the level of analgesia required for the surgical procedure. Ultrasonographic measurements of optic nerve sheath diameter and near-infrared spectrometry measurement of cerebral oxygenation will be taken before and after caudal anesthesia.
- Being tested
- Caudal anesthesia
- Keywords
- optic nerve sheath diameter, cerebral oximetry, caudal epidural anesthesia
- Medical subject headings
- Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caudal anesthesiaProcedure or surgery
Caudal epidural injection will be performed after induction of general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Low Volume | Active comparator | Caudal anesthesia will be performed with 0.8 ml/kg of the local anesthetic solution Receives: Procedure: Caudal anesthesia |
| High Volume | Active comparator | Caudal anesthesia will be performed with 1.25 ml/kg of the local anesthetic solution Receives: Procedure: Caudal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in optic nerve sheath diameter
Difference in the percentage change of ultrasonographic measurement of optic nerve sheath diameter between groups
Measured: From before caudal injection to immediately, 10 min, 20 min and 30 min after.
Change in cerebral oxygenation
Difference in the change in near-infrared spectrometry measurement of cerebral oxygenation between the groups
Measured: From before caudal injection to immediately, 10 min, 20 min and 30 min after.
Secondary outcomes (2)
Variation in optic nerve sheath diameter
Difference in the percentage change of ultrasonographic measurement of optic nerve sheath diameter in each group
Measured: From before caudal injection to immediately, 10 min, 20 min and 30 min after.
Variation in cerebral oxygenation
Difference in the change in near-infrared spectrometry measurement of cerebral oxygenation in each group
Measured: From before caudal injection to immediately, 10 min, 20 min and 30 min after.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start15 Feb 2019
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, CaudalStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will receive either a low or high volume of caudal injection.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aybike Onur Gönen
- Sponsor type
- University, hospital or other
- Collaborators
- Pinar Kendigelen, Ayse Cigdem Tutuncu, Kaya, Guner, M.D., Senol Emre, Rahsan Ozcan
- Responsible party
- Sponsor-investigator, Aybike Onur Gönen, Istanbul University
- Investigators
- Aybike Onur Gönen, MD, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491032
- Sponsor's protocol ID
- 72109855-604.01.01-10728
- Status last verified
- Jun 2022
- First submitted
- 27 Jul 2020
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No formal plans to share IPD is made
Publications
Gonen AO, Kaya G, Tutuncu AC, Ozcan R, Emre S, Kendigelen P. Effect of paediatric caudal injection volume on optic nerve sheath diameter and regional cerebral oximetry: A randomised trial. Eur J Anaesthesiol. 2023 Jul 1;40(7):465-471. doi: 10.1097/EJA.0000000000001819. Epub 2023 Mar 20.
PubMed 36938985
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Caudal Epidural Injection Volume on Optic Nerve Sheath Diameter and Cerebral Oxygenation in Pediatric Cases
- ClinicalTrials.gov ID
- NCT04491032
- Acronym / sponsor ID
- 72109855-604.01.01-10728
- Keywords
- optic nerve sheath diameter, cerebral oximetry, caudal epidural anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Aybike Onur GönenUniversity, hospital or other
- Collaborators
- Pinar Kendigelen, Ayse Cigdem Tutuncu, Kaya, Guner, M.D., Senol Emre, Rahsan Ozcan
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 29 Jul 2020 (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.
Caudal anesthesia is a commonly used neuraxial anesthesia method for children. Injection of a certain volume of fluid into the epidural space for cauda anesthesia may push some cerebrospinal fluid towards the head, which may lead to mild increase of pressures inside the head. Such mild changes are compensated well by healthy individuals and no clinical sequel is seen, however at-risk populations may be affected. We aim to see how different amounts of fluid injected into the epidural space may change two clinical parameters affected by intracranial pressure to determine if a lower volume is safer than a higher one.
Detailed description
Caudal epidural injection of local anesthetic solution is a common neuraxial anesthesia technique that provides excellent peri-operative analgesia in children. Unfused sacral hiatus allows for easy and safe access into the epidural space. Anatomically, injection of a certain volume of fluid over the dural sac inside the closed spinal canal can push the cerebrospinal fluid cranially. This push may lead to increased intracranial pressure. We will measure two findings affected by intracranial pressure (optic nerve sheath diameter and cerebral oxygenation) and compare the effects of two different volumes of caudal injections on these measures.
Children with closed fontanelles and scheduled to undergo elective surgery, for which caudal anesthesia is an effective method for peri-operative analgesia, will be recruited for this study. Injection volume will be determined depending on the level of analgesia required for the surgical procedure. Ultrasonographic measurements of optic nerve sheath diameter and near-infrared spectrometry measurement of cerebral oxygenation will be taken before and after caudal anesthesia.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will receive either a low or high volume of caudal injection.
| Arm | Type | Receives |
|---|---|---|
| Low Volume | Active comparator | Procedure: Caudal anesthesiaCaudal anesthesia will be performed with 0.8 ml/kg of the local anesthetic solution |
| High Volume | Active comparator | Procedure: Caudal anesthesiaCaudal anesthesia will be performed with 1.25 ml/kg of the local anesthetic solution |
Who may qualify
- Ages
- 12 months to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- ASA class 1 or 2
- Scheduled for elective surgery suitable for caudal anesthesia
- Parental/guardian consent for caudal anesthesia and measurements obtained
- Closed fontanelles
Key exclusion criteria (9 listed)
- Open fontanelle
- Parental/guardian refusal
- Previous intracranial or ocular pathology
- Coagulapathies
- Variations in gross and ultrasonographic sacral anatomy
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 anesthesiaCaudal epidural injection will be performed after induction of general anesthesia. | Procedure or surgery | High Volume, Low Volume |
Primary outcome
Change in optic nerve sheath diameter
Time frame: From before caudal injection to immediately, 10 min, 20 min and 30 min after.
Difference in the percentage change of ultrasonographic measurement of optic nerve sheath diameter between groups
Change in cerebral oxygenation
Time frame: From before caudal injection to immediately, 10 min, 20 min and 30 min after.
Difference in the change in near-infrared spectrometry measurement of cerebral oxygenation between the groups
2 secondary outcomes
Variation in optic nerve sheath diameter
Time frame: From before caudal injection to immediately, 10 min, 20 min and 30 min after.
Variation in cerebral oxygenation
Time frame: From before caudal injection to immediately, 10 min, 20 min and 30 min after.
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 30 Jun 2022.
- Derived from this study: PubMed 36938985Gonen AO, Kaya G, Tutuncu AC, Ozcan R, Emre S, Kendigelen P. Effect of paediatric caudal injection volume on optic nerve sheath diameter and regional cerebral oximetry: A randomised trial. Eur J Anaesthesiol. 2023 Jul 1;40(7):465-471. doi: 10.1097/EJA.0000000000001819. Epub 2023 Mar 20.
- Individual participant dataSharing planned: No. No formal plans to share IPD is made
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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.
Aybike Onur Gönen, MD study director
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caudal anesthesia in people with Anesthesia, Caudal and Pediatrics, run by Aybike Onur Gönen 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 4 inclusion and 9 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 30 Jun 2022. 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?
Change in optic nerve sheath diameter (time frame: From before caudal injection to immediately, 10 min, 20 min and 30 min after.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04491032, which also lists 1 linked publication.
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 30 Jun 2022.