Optic Nerve Sheath DiameterNCT03362255
Measurement of Optic Nerve Sheath Diameter
A study testing thoracic epidural catheterization in people with Optic Nerve Sheath Diameter, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Optic Nerve Sheath Diameter
- What is being tested?
- thoracic epidural catheterization
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Nov 2017to 5 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- lung cancer
- liver cancer
- stomach cancer
- pancreas cancer
Who cannot join
- coagulopathy
- infection
- previous spine fusion at thoracic level
- previous brain surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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).
- Conditions
- Optic Nerve Sheath Diameter
- Being tested
- thoracic epidural catheterization
- Keywords
- Optic Nerve Sheath Diameter Injection Speed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracic epidural catheterizationOther
thoracic epidural catheterization with different speed of injection
| Study group | Role | What they receive |
|---|---|---|
| Rapid speed of injection | Active comparator | Rapid speed of injection (3cc/sec) during thoracic epidurography thoracic epidural catheterization Receives: Other: thoracic epidural catheterization |
| Slow speed of injection | Active comparator | Slow speed of injection (1cc/sec) during thoracic epidurography thoracic epidural catheterization Receives: Other: thoracic epidural catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
optic nerve sheath diameter change among 4 time period
optic nerve sheath diameter change among 4 time period using ultrasound
Measured: Baseline, 1 minutes, 10 minutes, 30 minutes after the completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start13 Nov 2017
- Primary completion5 May 2018
- Study completion5 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Optic Nerve Sheath DiameterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Hee Hong, Keimyung University Dongsan Medical Center
- Investigators
- Ji Hee Hong, PhD, Principal investigator, Keimyung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03362255
- Sponsor's protocol ID
- 2017-08-017
- Status last verified
- Jul 2018
- First submitted
- 28 Nov 2017
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hong JH, Jung SW, Park JH. The Effect of Speed of Normal Saline Injection on Optic Nerve Sheath Diameter in Thoracic Epidural Anesthesia. Pain Physician. 2019 Jul;22(4):E325-E332.
PubMed 31337174
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Speed of Normal Saline Injection on Optic Nerve Sheath Diameter During Thoracic Epidural Catheterization
- ClinicalTrials.gov ID
- NCT03362255
- Acronym / sponsor ID
- 2017-08-017
- Conditions
- Optic Nerve Sheath Diameter
- Keywords
- Optic Nerve Sheath Diameter Injection Speed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 5 May 2018 (actual)
- Study completion
- 5 May 2018 (actual)
- First posted
- 5 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapid speed of injection | Active comparator | Other: thoracic epidural catheterizationRapid speed of injection (3cc/sec) during thoracic epidurography thoracic epidural catheterization |
| Slow speed of injection | Active comparator | Other: thoracic epidural catheterizationSlow speed of injection (1cc/sec) during thoracic epidurography thoracic epidural catheterization |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- lung cancer
- liver cancer
- stomach cancer
- pancreas cancer
Key exclusion criteria (4 listed)
- coagulopathy
- infection
- previous spine fusion at thoracic level
- previous brain surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thoracic epidural catheterizationthoracic epidural catheterization with different speed of injection | Other | Rapid speed of injection, Slow speed of injection |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
- Derived from this study: PubMed 31337174Hong JH, Jung SW, Park JH. The Effect of Speed of Normal Saline Injection on Optic Nerve Sheath Diameter in Thoracic Epidural Anesthesia. Pain Physician. 2019 Jul;22(4):E325-E332.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ji Hee Hong, PhD principal investigator
Keimyung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thoracic epidural catheterization in people with Optic Nerve Sheath Diameter, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
optic nerve sheath diameter change among 4 time period (time frame: Baseline, 1 minutes, 10 minutes, 30 minutes after the completion of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03362255, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2018.