Effect of Contrast Medium on Optic Nerve Sheath Diameter

: Effect of Epidural Injection of Normal Saline or Contrast Medium on Optic Nerve Sheath Diameter

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04826042

Enrollment

Registered

2021-04-01

Start date

2021-03-29

Completion date

2022-08-29

Last updated

2022-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Optic Nerve Sheath Diameter

Keywords

optic nerve sheath diameter

Brief summary

One method of indirect measurement of intracranial pressure is using optic nerve sheath diameter. There is no study whether equal volume of contrast medium injection has any increasing effect of optic nerve sheath diameter. This study is designed to measure the changes of optic nerve sheath diameter and cerebral oxygenation when equal volume of contrast medium or normal saline was injected in epidural space.

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 equal volume of contrast medium or normal saline was injected in epidural space.

Interventions

OTHERthoracic epidural catheterization

thoracic epidural catheterization

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Inclusion criteria

* lung cancer * liver cancer * stomach cancer * pancreas cancer * gallbladder

Exclusion criteria

* coagulopathy * infection * previous spine fusion at thoracic level * previous brain lesion

Design outcomes

Primary

Measure	Time frame	Description
optic nerve sheath change during 4 time period	Baseline, 10 minutes, 20 minutes, 40 minutes after the completion of the intervention	optic nerve sheath change during 4 time period using ultrasound

Secondary

Measure	Time frame	Description
cerebral oxygenation change during 4 time period	Baseline, 10 minutes, 20 minutes, 40 minutes after the completion of the intervention	cerebral oxygenation change during 4 time period using cerebral oximeter

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026