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Effect of Contrast Medium on Optic Nerve Sheath Diameter

NCT ID: NCT04826042

Last Updated: 2022-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-29

Study Completion Date

2022-08-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Optic Nerve Sheath Diameter

Keywords

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optic nerve sheath diameter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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contrast group

injection of contrast medium 6 cc during thoracic epidural catheterization

Group Type ACTIVE_COMPARATOR

thoracic epidural catheterization

Intervention Type OTHER

thoracic epidural catheterization

normal saline group

injection of normal saline 6 cc during thoracic epidural catheterization

Group Type PLACEBO_COMPARATOR

thoracic epidural catheterization

Intervention Type OTHER

thoracic epidural catheterization

Interventions

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thoracic epidural catheterization

thoracic epidural catheterization

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* lung cancer
* liver cancer
* stomach cancer
* pancreas cancer
* gallbladder

Exclusion Criteria

* coagulopathy
* infection
* previous spine fusion at thoracic level
* previous brain lesion
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Keimyung University Dongsan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Ji Hee Hong

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ji Hee Hong

Daegu, , South Korea

Site Status

Countries

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South Korea

References

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Hong JH, Park JH, Park KB. Comparison of Increase in the Optic Nerve Sheath Diameter between Epidural Saline and Contrast Medium Injections. Pain Physician. 2022 Mar;25(2):E263-E269.

Reference Type DERIVED
PMID: 35322981 (View on PubMed)

Other Identifiers

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2021-01-042

Identifier Type: -

Identifier Source: org_study_id