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

NCT04491032 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2022-06-30

No results posted yet for this study

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

Interventions

PROCEDURE

Caudal anesthesia

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

Sponsors & Collaborators

  • Pinar Kendigelen

    collaborator UNKNOWN

  • Ayse Cigdem Tutuncu

    collaborator OTHER

  • Kaya, Guner, M.D.

    collaborator INDIV

  • Senol Emre

    collaborator UNKNOWN

  • Rahsan Ozcan

    collaborator UNKNOWN

  • Aybike Onur Gönen

    lead OTHER

Principal Investigators

  • Aybike Onur Gönen, MD · Istanbul University - Cerrahpasa

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-15
Primary Completion
2022-03-15
Completion
2022-03-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04491032 on ClinicalTrials.gov