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| Name | Class |
|---|---|
| Pinar Kendigelen | UNKNOWN |
| Ayse Cigdem Tutuncu | OTHER |
| Kaya, Guner, M.D. | INDIV |
| Senol Emre |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Volume | Active Comparator | Caudal anesthesia will be performed with 0.8 ml/kg of the local anesthetic solution |
|
| High Volume | Active Comparator | Caudal anesthesia will be performed with 1.25 ml/kg of the local anesthetic solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caudal anesthesia | Procedure | Caudal epidural injection will be performed after induction of general anesthesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in optic nerve sheath diameter | Difference in the percentage change of ultrasonographic measurement of optic nerve sheath diameter between groups | 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 | From before caudal injection to immediately, 10 min, 20 min and 30 min after. |
| Measure | Description | Time Frame |
|---|---|---|
| Variation in optic nerve sheath diameter | Difference in the percentage change of ultrasonographic measurement of optic nerve sheath diameter in each group | From before caudal injection to immediately, 10 min, 20 min and 30 min after. |
| Variation in cerebral oxygenation |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in hemodynamic and respiratory parameters | Mean arterial pressure, heart rate, end-tidal carbondioxide pressure, peak inspiratory pressure, peripheral oxygen saturation, oxygen fraction of inhaled gas | From before caudal injection to immediately, 10 min, 20 min and 30 min after. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aybike Onur Gönen, MD | Istanbul University - Cerrahpasa | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University Cerrahpasa | Istanbul | 34098 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36938985 | Derived | 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. |
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No formal plans to share IPD is made
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| ID | Term |
|---|---|
| D019586 | Intracranial Hypertension |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000763 | Anesthesia, Caudal |
| ID | Term |
|---|---|
| D000767 | Anesthesia, Epidural |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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| UNKNOWN |
| Rahsan Ozcan | UNKNOWN |
Patients will receive either a low or high volume of caudal injection.
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Investigator, who will take and record the measurements, will not know about the volume of caudal injection. Another investigator will analyze the ultrasonography images without any knowledge of the patient or the intervention.
Difference in the change in near-infrared spectrometry measurement of cerebral oxygenation in each group |
| From before caudal injection to immediately, 10 min, 20 min and 30 min after. |