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NCT Number: NCT04826042

Effect of Contrast Medium on Optic Nerve Sheath Diameter

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.

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Key information

Conditions

Optic Nerve Sheath Diameter

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ji Hee Hong

Daegu, 700712, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

thoracic epidural catheterization

Other

thoracic epidural catheterization

Primary outcomes

  1. optic nerve sheath change during 4 time period

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

    optic nerve sheath change during 4 time period using ultrasound

Secondary outcomes

  1. cerebral oxygenation change during 4 time period

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

    cerebral oxygenation change during 4 time period using cerebral oximeter

Sponsors and collaborators

Lead sponsor

Keimyung University Dongsan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 1, 2021
Registry last updated
Dec 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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