Optic Nerve Sheath Diameter Difference Between Different Injection Volume

Optic Nerve Sheath Diameter Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04412109
• Other study ID #: 2020-01-081
• Status: Completed
• Phase: N/A
• Start date: May 25, 2020
• Est. completion date: November 16, 2020

Study information

• Verified date: November 2020
• Source: Keimyung University Dongsan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 16, 2020
• Est. primary completion date: November 16, 2020
• 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 cancer

Exclusion Criteria:

• coagulopathy

• infection

• previous spine fusion at thoracic level

• previous brain lesion causing increased intracranial pressure

Related Conditions & MeSH terms

• Optic Nerve Sheath Diameter

Intervention

Procedure:
• thoracic epidural catheterization
thoracic epidural catheterization for postoperative pain control

Locations

Country	Name	City	State
Korea, Republic of	Hong ji HEE	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 pressure monitoring kit	Baseline, 10 minutes, 20 minutes, 40 minutes after the completion of the intervention