Effect of Contrast Medium on Optic Nerve Sheath Diameter

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Optic Nerve Sheath Diameter

Intervention / Treatment
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* Other: thoracic epidural catheterization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: lung cancer liver cancer stomach cancer pancreas cancer gallbladder Exclusion Criteria: coagulopathy infection previous spine fusion at thoracic level previous brain lesion

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: contrast group<br>injection of contrast medium 6 cc during thoracic epidural catheterization | Other: thoracic epidural catheterization<br>* thoracic epidural catheterization<br>|
| Placebo Comparator: normal saline group<br>injection of normal saline 6 cc during thoracic epidural catheterization | Other: thoracic epidural catheterization<br>* thoracic epidural catheterization<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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optic nerve sheath diameter