Optic Nerve Sheath Diameter Difference Between Different Injection Volume

November 16, 2020 updated by: Ji Hee Hong, Keimyung University Dongsan Medical Center

Effect of Normal Saline Injection Volume on Epidural Pressure and Optic Nerve Sheath Diameter

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.

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 different volume of normal saline was injected.

Study Type

Interventional

Enrollment (Actual)

50

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
  • gallbladder cancer

Exclusion Criteria:

  • coagulopathy
  • infection
  • previous spine fusion at thoracic level
  • previous brain lesion causing increased intracranial pressure

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: injection of low volume of saline
low volume (5 cc) saline injection during thoracic epidural catheterization
Procedure: thoracic epidural catheterization
thoracic epidural catheterization for postoperative pain control
Active Comparator: injection of intermediate volume of saline
intermediate volume (10 cc) saline injection during thoracic epidural catheterization
Procedure: thoracic epidural catheterization
thoracic epidural catheterization for postoperative pain control
Active Comparator: injection of high volume of saline
high volume (20 cc) saline injection during thoracic epidural catheterization
Procedure: thoracic epidural catheterization
thoracic epidural catheterization for postoperative pain control

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 pressure monitoring kit
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)

May 25, 2020

Primary Completion (Actual)

November 16, 2020

Study Completion (Actual)

November 16, 2020

Study Registration Dates

First Submitted

May 28, 2020

First Submitted That Met QC Criteria

May 28, 2020

First Posted (Actual)

June 2, 2020

Study Record Updates

Last Update Posted (Actual)

November 18, 2020

Last Update Submitted That Met QC Criteria

November 16, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2020-01-081

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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