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Measurement of Optic Nerve Sheath Diameter

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03362255
Recruitment Status : Completed
First Posted : December 5, 2017
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
Ji Hee Hong, Keimyung University Dongsan Medical Center

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Optic Nerve Sheath Diameter Other: thoracic epidural catheterization Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Different Speed of Normal Saline Injection on Optic Nerve Sheath Diameter During Thoracic Epidural Catheterization
Actual Study Start Date : November 13, 2017
Actual Primary Completion Date : May 5, 2018
Actual Study Completion Date : May 5, 2018

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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362255


Locations
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Korea, Republic of
Ji Hee Hong
Daegu, Korea, Republic of, 700712
Sponsors and Collaborators
Keimyung University Dongsan Medical Center
Investigators
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Principal Investigator: Ji Hee Hong, PhD Keimyung University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ji Hee Hong, Professor, Keimyung University Dongsan Medical Center
ClinicalTrials.gov Identifier: NCT03362255    
Other Study ID Numbers: 2017-08-017
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ji Hee Hong, Keimyung University Dongsan Medical Center:
Optic Nerve Sheath Diameter Injection Speed