Measurement of Optic Nerve Sheath Diameter

NCT ID: NCT03362255

Last Updated: 2018-07-03

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-13

Study Completion Date

2018-05-05

Brief Summary

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It is reported that optic nerve sheath diameter increases when higher volume of medication is injected during epidural anesthesia.

This study is designed to compare the optic nerve sheath diameter using 10cc of nomal saline of different speed (3cc/sec vs. 1cc/sec).

Detailed Description

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It is known that insufficient intraoperative or postoperative management can lengthen the hospital stay with unwanted complications. Therefore, active and proper management using continuous thoracic epidural catheterization is suggested good option to prevent such potential complication.

According to previous study, injection of different volume of local anesthetics (1.0 ml/kg vs. 1.5 ml/kg) during caudal anesthesia, high volume of local anesthetics resulted in significant increase of intracranial pressure (ICP). Increase of ICP can reduce regional cerebral flow and oxygen saturation causing the safety of patients. In addition, increase of ICP can result in headache, syncope, and transient loss of visual acuity.

Although it is very invasive method, ICP can be measured directly at the brain parenchyme. Among methods to measure the ICP indirectly, measurement of optic nerve sheath diameter using ultrasound is known to reflect the degree of ICP. It is reported that optic nerve sheath diameter increases when higher volume of medication is injected during epidural anesthesia.

This study is designed to compare the optic nerve sheath diameter using 10cc of nomal saline of different speed (3cc/sec vs. 1cc/sec).

Conditions

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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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Rapid speed of injection

Rapid speed of injection (3cc/sec) during thoracic epidurography thoracic epidural catheterization

Group Type ACTIVE_COMPARATOR

thoracic epidural catheterization

Intervention Type OTHER

thoracic epidural catheterization with different speed of injection

Slow speed of injection

Slow speed of injection (1cc/sec) during thoracic epidurography thoracic epidural catheterization

Group Type ACTIVE_COMPARATOR

thoracic epidural catheterization

Intervention Type OTHER

thoracic epidural catheterization with different speed of injection

Interventions

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thoracic epidural catheterization

thoracic epidural catheterization with different speed of injection

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* coagulopathy
* infection
* previous spine fusion at thoracic level
* previous brain surgery
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

Principal Investigators

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Ji Hee Hong, PhD

Role: PRINCIPAL_INVESTIGATOR

Keimyung University

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, Jung SW, Park JH. The Effect of Speed of Normal Saline Injection on Optic Nerve Sheath Diameter in Thoracic Epidural Anesthesia. Pain Physician. 2019 Jul;22(4):E325-E332.

Reference Type DERIVED
PMID: 31337174 (View on PubMed)

Other Identifiers

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2017-08-017

Identifier Type: -

Identifier Source: org_study_id

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