Optic Nerve Sheath Diameter Difference Between Different Injection Volume

Not Applicable

Completed

• Conditions: Optic Nerve Sheath Diameter

• Registration Number: NCT04412109
• Lead Sponsor: Keimyung University Dongsan Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-05-25
• Study First Submitted: 2020-05-28
• Study First Submitted QC: 2020-05-28
• Study First Posted: 2020-06-02
• Status Verified: 2020-11
• Primary Completion: 2020-11-16
• Study Completion: 2020-11-16
• Last Update Submitted: 2020-11-16
• Last Update Posted: 2020-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
optic nerve sheath change during 4 time period	Baseline, 10 minutes, 20 minutes, 40 minutes after the completion of the intervention	optic nerve sheath change during 4 time period using ultrasound

Secondary Outcome Measures

Name	Time	Method
cerebral oxygenation change during 4 time period	Baseline, 10 minutes, 20 minutes, 40 minutes after the completion of the intervention	cerebral oxygenation change during 4 time period using pressure monitoring kit

Trial Locations

Locations (1)

Hong ji HEE; 🇰🇷 Daegu, Korea, Republic of