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Optic Nerve Sheath Diameter Difference Between Different Injection Volume

NCT ID: NCT04412109

Last Updated: 2020-11-18

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-25

Study Completion Date

2020-11-16

Brief Summary

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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

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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 different volume of normal saline was injected.

Conditions

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Optic Nerve Sheath Diameter

Keywords

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Optic Nerve Sheath Diameter, Different volume

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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injection of low volume of saline

low volume (5 cc) saline injection during thoracic epidural catheterization

Group Type ACTIVE_COMPARATOR

thoracic epidural catheterization

Intervention Type PROCEDURE

thoracic epidural catheterization for postoperative pain control

injection of intermediate volume of saline

intermediate volume (10 cc) saline injection during thoracic epidural catheterization

Group Type ACTIVE_COMPARATOR

thoracic epidural catheterization

Intervention Type PROCEDURE

thoracic epidural catheterization for postoperative pain control

injection of high volume of saline

high volume (20 cc) saline injection during thoracic epidural catheterization

Group Type ACTIVE_COMPARATOR

thoracic epidural catheterization

Intervention Type PROCEDURE

thoracic epidural catheterization for postoperative pain control

Interventions

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thoracic epidural catheterization

thoracic epidural catheterization for postoperative pain control

Intervention Type PROCEDURE

Eligibility Criteria

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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
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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Hong ji HEE

Daegu, , South Korea

Site Status

Countries

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South Korea

References

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Hong J, Kim JS, Lee YH. The Effect of Normal Saline Injection Volumes on the Optic Nerve Sheath Diameter during Thoracic Epidural Analgesia. Pain Physician. 2021 Nov;24(7):E1007-E1013.

Reference Type DERIVED
PMID: 34704711 (View on PubMed)

Other Identifiers

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2020-01-081

Identifier Type: -

Identifier Source: org_study_id