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Optic Nerve Sheath Diameter Difference Between Different Injection Volume

K

Keimyung University

Status

Completed

Conditions

Optic Nerve Sheath Diameter

Treatments

Procedure: thoracic epidural catheterization

Study type

Interventional

Funder types

Other

Identifiers

NCT04412109
2020-01-081

Details and patient eligibility

About

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.

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 different volume of normal saline was injected.

Enrollment

50 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 3 patient groups

injection of low volume of saline
Active Comparator group
Description:
low volume (5 cc) saline injection during thoracic epidural catheterization
Treatment:
Procedure: thoracic epidural catheterization
injection of intermediate volume of saline
Active Comparator group
Description:
intermediate volume (10 cc) saline injection during thoracic epidural catheterization
Treatment:
Procedure: thoracic epidural catheterization
injection of high volume of saline
Active Comparator group
Description:
high volume (20 cc) saline injection during thoracic epidural catheterization
Treatment:
Procedure: thoracic epidural catheterization

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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