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Effect of Contrast Medium on Optic Nerve Sheath Diameter

K

Keimyung University

Status

Completed

Conditions

Optic Nerve Sheath Diameter

Treatments

Other: thoracic epidural catheterization

Study type

Interventional

Funder types

Other

Identifiers

NCT04826042
2021-01-042

Details and patient eligibility

About

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.

Full 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.

Enrollment

42 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

42 participants in 2 patient groups, including a placebo group

contrast group
Active Comparator group
Description:
injection of contrast medium 6 cc during thoracic epidural catheterization
Treatment:
Other: thoracic epidural catheterization
normal saline group
Placebo Comparator group
Description:
injection of normal saline 6 cc during thoracic epidural catheterization
Treatment:
Other: thoracic epidural catheterization

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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