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

NCT04491032 | Completed

• 1 other identifier: 72109855-604.01.01-10728
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, Caudal; Pediatrics; Elevated Intracranial Pressure

Keywords

optic nerve sheath diameter; cerebral oximetry; caudal epidural anesthesia

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (2)

• Variation in optic nerve sheath diameter

  From before caudal injection to immediately, 10 min, 20 min and 30 min after.

• Variation in cerebral oxygenation

  From before caudal injection to immediately, 10 min, 20 min and 30 min after.

Other Outcomes (1)

• Changes in hemodynamic and respiratory parameters

  From before caudal injection to immediately, 10 min, 20 min and 30 min after.

Study Arms (2)

Low Volume

ACTIVE COMPARATOR

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

Procedure: Caudal anesthesia

High Volume

ACTIVE COMPARATOR

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

Procedure: Caudal anesthesia

Interventions

Caudal anesthesia PROCEDURE

Caudal epidural injection will be performed after induction of general anesthesia.

High Volume; Low Volume

Eligibility Criteria

• Age: 12 Months - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aybike Onur Gönen: lead
• Pinar Kendigelen: collaborator
• Ayse Cigdem Tutuncu: collaborator
• Kaya, Guner, M.D.: collaborator
• Senol Emre: collaborator
• Rahsan Ozcan: collaborator

Study Sites (1)

Istanbul University Cerrahpasa

Istanbul, 34098, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 36938985 DERIVED

MeSH Terms

Conditions

Intracranial Hypertension

Interventions

Anesthesia, Caudal

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Epidural; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Aybike Onur Gönen, MD

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident in Anesthesiology and Intensive Care

Model Details: Patients will receive either a low or high volume of caudal injection.

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: July 29, 2020
• Study Start: February 15, 2019
• Primary Completion: March 15, 2022
• Study Completion: March 15, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)