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CompletedNCT04412109Updated Nov 18, 2020

Optic Nerve Sheath Diameter Difference Between Different Injection Volume

An interventional study of thoracic epidural catheterization in Optic Nerve Sheath Diameter, sponsored by Keimyung University Dongsan Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-11-18.

Sponsored by Keimyung University Dongsan Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study summary

Valid method of indirect measurement of intracranial pressure is using optic nerve sheath diameter. Different volume of injection is known to affect the degree of increase of intracranial pressure.

This study is desinged to measure the changes of optic nerve sheath diameter and cerebral oxygenation when different volume of normal saline was injected.

Read the detailed description

Previous study showed that different volume of injections (1.0 ml/kg vs. 1.5 ml/kg) during caudal anesthesia showed siginifiant increase of optic nerve sheath diameter in group of high volumes. Increase of ICP can result in harmful effect including reduced cerebral flow and oxygen saturation. Also, increase of ICP can cause headache, syncope and transient loss of visual acuity. The proven and valid method of measuring ICP indirectly is using optic nerve sheath diameter.

This study was designed to examine the changes of optic nerve sheath diameter and cerebral oxygenation when different volume of normal saline was injected.

02

Conditions studied

  • Optic Nerve Sheath Diameter

Keywords

  • Optic Nerve Sheath Diameter, Different volume
03

In context

Lead sponsor

Keimyung University Dongsan Medical Center is the lead sponsor of 81 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • lung cancer
  • liver cancer
  • stomach cancer
  • pancreas cancer
  • gallbladder cancer

Exclusion criteria

Exclusion Criteria:

  • coagulopathy
  • infection
  • previous spine fusion at thoracic level
  • previous brain lesion causing increased intracranial pressure
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Active comparator
    injection of low volume of saline

    low volume (5 cc) saline injection during thoracic epidural catheterization

    Procedure: thoracic epidural catheterization

  • Active comparator
    injection of intermediate volume of saline

    intermediate volume (10 cc) saline injection during thoracic epidural catheterization

    Procedure: thoracic epidural catheterization

  • Active comparator
    injection of high volume of saline

    high volume (20 cc) saline injection during thoracic epidural catheterization

    Procedure: thoracic epidural catheterization

Interventions

  • Procedurethoracic epidural catheterization

    thoracic epidural catheterization for postoperative pain control

06

What researchers measure

Primary outcomes

  1. optic nerve sheath change during 4 time period

    optic nerve sheath change during 4 time period using ultrasound

    Time frame: Baseline, 10 minutes, 20 minutes, 40 minutes after the completion of the intervention

Secondary outcomes

  1. cerebral oxygenation change during 4 time period

    cerebral oxygenation change during 4 time period using pressure monitoring kit

    Time frame: Baseline, 10 minutes, 20 minutes, 40 minutes after the completion of the intervention

07

Study locations

1 site
  • Hong ji HEE
    Daegu, 42601, Korea, Republic of
08

References and documents

Publications

  • Hong J, Kim JS, Lee YH. The Effect of Normal Saline Injection Volumes on the Optic Nerve Sheath Diameter during Thoracic Epidural Analgesia. Pain Physician. 2021 Nov;24(7):E1007-E1013. PubMed 34704711 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04412109
Lead sponsor
Keimyung University Dongsan Medical Center
Responsible party
Ji Hee Hong (Professor, Keimyung University Dongsan Medical Center) — Principal investigator
First posted
Jun 2, 2020
Start date
May 25, 2020
Primary completion
Nov 16, 2020
Completion
Nov 16, 2020
Last update
Nov 18, 2020

Study contacts

Ji Hee Hong, PhD
principal investigator · Keimyung University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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