Optic Nerve Sheath Diameter Difference

February 20, 2020 updated by: Ji Hee Hong, Keimyung University Dongsan Medical Center

Effect of Different Posture on Optic Nerve Sheath Diameter During Thoracic Epidural Catheterization

Intracranial pressure is measured indirectly using optic nerve sheath diameter with ultrasound. It is reported that epidural pressure varies according to different posture ( lateral decubitus vs. sitting position).

This study is designed to measure the optic nerve sheath diameter in lateral decubitus and sitting position, respectively.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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. Previous reports showed that epidural pressure varies according to different posture. When epidural pressure was measured in patients of spinal stenosis, lumbar flexion showed lower epidural pressure than epidural pressure of lumbar extension. In addition, when epidural pressure was measured in the sitting position, it showed lower pressure than pressure of lateral decubitus.

Study Type

Interventional

Enrollment (Actual)

44

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: injection under sitting position
saline injection under sitting position during thoracic epidural catheterization
Other: thoracic epidural catheterization
thoracic epidural catheterization with different posture
ACTIVE_COMPARATOR: injection under lateral decubitus position
saline injection under lateral decubitus position during thoracic epidural catheterization
Other: thoracic epidural catheterization
thoracic epidural catheterization with different posture

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, 10 minutes, 20 minutes, 40 minutes after the completion of the intervention
optic nerve sheath diameter change among 4 time period using ultrasound
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

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)

January 2, 2019

Primary Completion (ACTUAL)

October 30, 2019

Study Completion (ACTUAL)

December 30, 2019

Study Registration Dates

First Submitted

December 20, 2018

First Submitted That Met QC Criteria

December 20, 2018

First Posted (ACTUAL)

December 24, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 24, 2020

Last Update Submitted That Met QC Criteria

February 20, 2020

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2018-11-039

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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