Effect of Contrast Medium on Optic Nerve Sheath Diameter

Optic Nerve Sheath Diameter Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04826042
• Other study ID #: 2021-01-042
• Status: Completed
• Phase: N/A
• Start date: March 29, 2021
• Est. completion date: August 29, 2022

Study information

• Verified date: December 2022
• Source: Keimyung University Dongsan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 29, 2022
• Est. primary completion date: August 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Optic Nerve Sheath Diameter

Intervention

Other:
• thoracic epidural catheterization
thoracic epidural catheterization

Locations

Country	Name	City	State
Korea, Republic of	Ji Hee Hong	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Keimyung University Dongsan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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