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Pediatric Caudal Injection Volume on Optic Nerve Sheath Diameter and Cerebral Oxygenation

Primary Purpose

Anesthesia, Caudal, Pediatrics, Elevated Intracranial Pressure

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Caudal anesthesia
Sponsored by
Aybike Onur Gönen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Anesthesia, Caudal focused on measuring optic nerve sheath diameter, cerebral oximetry, caudal epidural anesthesia

Eligibility Criteria

12 Months - 8 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA class 1 or 2
  • Scheduled for elective surgery suitable for caudal anesthesia
  • Parental/guardian consent for caudal anesthesia and measurements obtained
  • Closed fontanelles

Exclusion Criteria:

  • 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
  • Block volumes more than 30ml needed
  • Laparoscopic surgery
  • Need for long term analgesia with epidural catheter

Sites / Locations

  • Istanbul University Cerrahpasa

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Low Volume

High Volume

Arm Description

Caudal anesthesia will be performed with 0.8 ml/kg of the local anesthetic solution

Caudal anesthesia will be performed with 1.25 ml/kg of the local anesthetic solution

Outcomes

Primary Outcome Measures

Change in optic nerve sheath diameter
Difference in the percentage change of ultrasonographic measurement of optic nerve sheath diameter between groups
Change in cerebral oxygenation
Difference in the change in near-infrared spectrometry measurement of cerebral oxygenation between the groups

Secondary Outcome Measures

Variation in optic nerve sheath diameter
Difference in the percentage change of ultrasonographic measurement of optic nerve sheath diameter in each group
Variation in cerebral oxygenation
Difference in the change in near-infrared spectrometry measurement of cerebral oxygenation in each group

Full Information

First Posted
July 27, 2020
Last Updated
June 29, 2022
Sponsor
Aybike Onur Gönen
Collaborators
Pinar Kendigelen, Ayse Cigdem Tutuncu, Kaya, Guner, M.D., Senol Emre, Rahsan Ozcan
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1. Study Identification

Unique Protocol Identification Number
NCT04491032
Brief Title
Pediatric Caudal Injection Volume on Optic Nerve Sheath Diameter and Cerebral Oxygenation
Official Title
The Effect of Caudal Epidural Injection Volume on Optic Nerve Sheath Diameter and Cerebral Oxygenation in Pediatric Cases
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
February 15, 2019 (Actual)
Primary Completion Date
March 15, 2022 (Actual)
Study Completion Date
March 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Aybike Onur Gönen
Collaborators
Pinar Kendigelen, Ayse Cigdem Tutuncu, Kaya, Guner, M.D., Senol Emre, Rahsan Ozcan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Caudal, Pediatrics, Elevated Intracranial Pressure
Keywords
optic nerve sheath diameter, cerebral oximetry, caudal epidural anesthesia

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will receive either a low or high volume of caudal injection.
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Volume
Arm Type
Active Comparator
Arm Description
Caudal anesthesia will be performed with 0.8 ml/kg of the local anesthetic solution
Arm Title
High Volume
Arm Type
Active Comparator
Arm Description
Caudal anesthesia will be performed with 1.25 ml/kg of the local anesthetic solution
Intervention Type
Procedure
Intervention Name(s)
Caudal anesthesia
Intervention Description
Caudal epidural injection will be performed after induction of general anesthesia.
Primary Outcome Measure Information:
Title
Change in optic nerve sheath diameter
Description
Difference in the percentage change of ultrasonographic measurement of optic nerve sheath diameter between groups
Time Frame
From before caudal injection to immediately, 10 min, 20 min and 30 min after.
Title
Change in cerebral oxygenation
Description
Difference in the change in near-infrared spectrometry measurement of cerebral oxygenation between the groups
Time Frame
From before caudal injection to immediately, 10 min, 20 min and 30 min after.
Secondary Outcome Measure Information:
Title
Variation in optic nerve sheath diameter
Description
Difference in the percentage change of ultrasonographic measurement of optic nerve sheath diameter in each group
Time Frame
From before caudal injection to immediately, 10 min, 20 min and 30 min after.
Title
Variation in cerebral oxygenation
Description
Difference in the change in near-infrared spectrometry measurement of cerebral oxygenation in each group
Time Frame
From before caudal injection to immediately, 10 min, 20 min and 30 min after.
Other Pre-specified Outcome Measures:
Title
Changes in hemodynamic and respiratory parameters
Description
Mean arterial pressure, heart rate, end-tidal carbondioxide pressure, peak inspiratory pressure, peripheral oxygen saturation, oxygen fraction of inhaled gas
Time Frame
From before caudal injection to immediately, 10 min, 20 min and 30 min after.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA class 1 or 2 Scheduled for elective surgery suitable for caudal anesthesia Parental/guardian consent for caudal anesthesia and measurements obtained Closed fontanelles Exclusion Criteria: 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 Block volumes more than 30ml needed Laparoscopic surgery Need for long term analgesia with epidural catheter
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aybike Onur Gönen, MD
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul University Cerrahpasa
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No formal plans to share IPD is made

Learn more about this trial

Pediatric Caudal Injection Volume on Optic Nerve Sheath Diameter and Cerebral Oxygenation

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