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Completed

NCT Number: NCT04412109

Optic Nerve Sheath Diameter Difference Between Different Injection Volume

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.

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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

Hong ji HEE

Daegu, 42601, 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 different volume of normal saline was injected.

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 cancer

Exclusion criteria

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

Treatment and study plan

thoracic epidural catheterization

Procedure

thoracic epidural catheterization for postoperative pain control

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 pressure monitoring kit

Sponsors and collaborators

Lead sponsor

Keimyung University Dongsan Medical Center

Other

Registry information

Official study title

Effect of Normal Saline Injection Volume on Epidural Pressure and Optic Nerve Sheath Diameter

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 2, 2020
Registry last updated
Nov 18, 2020

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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