Effect of Contrast Medium on Optic Nerve Sheath Diameter

December 18, 2022 updated by: Ji Hee Hong, Keimyung University Dongsan Medical Center

: Effect of Epidural Injection of Normal Saline or Contrast Medium on Optic Nerve Sheath Diameter

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 equal volume of contrast medium or normal saline was injected in epidural space.

Study Type

Interventional

Enrollment (Actual)

42

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

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: contrast group
injection of contrast medium 6 cc during thoracic epidural catheterization
Other: thoracic epidural catheterization
thoracic epidural catheterization
Placebo Comparator: normal saline group
injection of normal saline 6 cc during thoracic epidural catheterization
Other: thoracic epidural catheterization
thoracic epidural catheterization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
optic nerve sheath change during 4 time period
Time Frame: Baseline, 10 minutes, 20 minutes, 40 minutes after the completion of the intervention
optic nerve sheath change during 4 time period using ultrasound
Baseline, 10 minutes, 20 minutes, 40 minutes after the completion of the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cerebral oxygenation change during 4 time period
Time Frame: Baseline, 10 minutes, 20 minutes, 40 minutes after the completion of the intervention
cerebral oxygenation change during 4 time period using cerebral oximeter
Baseline, 10 minutes, 20 minutes, 40 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)

March 29, 2021

Primary Completion (Actual)

August 29, 2022

Study Completion (Actual)

August 29, 2022

Study Registration Dates

First Submitted

March 29, 2021

First Submitted That Met QC Criteria

March 29, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

December 20, 2022

Last Update Submitted That Met QC Criteria

December 18, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2021-01-042

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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