Trials / Completed
CompletedNCT04491032
Pediatric Caudal Injection Volume on Optic Nerve Sheath Diameter and Cerebral Oxygenation
The Effect of Caudal Epidural Injection Volume on Optic Nerve Sheath Diameter and Cerebral Oxygenation in Pediatric Cases
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 58 (actual)
- Sponsor
- Aybike Onur Gönen · Academic / Other
- Sex
- All
- Age
- 12 Months – 8 Years
- Healthy volunteers
- Not accepted
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. 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Caudal anesthesia | Caudal epidural injection will be performed after induction of general anesthesia. |
Timeline
- Start date
- 2019-02-15
- Primary completion
- 2022-03-15
- Completion
- 2022-03-15
- First posted
- 2020-07-29
- Last updated
- 2022-06-30
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT04491032. Inclusion in this directory is not an endorsement.