Measurement of Optic Nerve Sheath Diameter

July 1, 2018 updated by: Ji Hee Hong, Keimyung University Dongsan Medical Center

Effect of Different Speed of Normal Saline Injection on Optic Nerve Sheath Diameter During Thoracic Epidural Catheterization

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • lung cancer
  • liver cancer
  • stomach cancer
  • pancreas cancer

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Rapid speed of injection
Rapid speed of injection (3cc/sec) during thoracic epidurography thoracic epidural catheterization
Other: thoracic epidural catheterization
thoracic epidural catheterization with different speed of injection
ACTIVE_COMPARATOR: Slow speed of injection
Slow speed of injection (1cc/sec) during thoracic epidurography thoracic epidural catheterization
Other: thoracic epidural catheterization
thoracic epidural catheterization with different speed of injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
optic nerve sheath diameter change among 4 time period
Time Frame: Baseline, 1 minutes, 10 minutes, 30 minutes after the completion of the intervention
optic nerve sheath diameter change among 4 time period using ultrasound
Baseline, 1 minutes, 10 minutes, 30 minutes after the completion of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keimyung University Dongsan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 13, 2017

Primary Completion (ACTUAL)

May 5, 2018

Study Completion (ACTUAL)

May 5, 2018

Study Registration Dates

First Submitted

November 28, 2017

First Submitted That Met QC Criteria

December 3, 2017

First Posted (ACTUAL)

December 5, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 3, 2018

Last Update Submitted That Met QC Criteria

July 1, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2017-08-017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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