Optic Nerve Sheath DiameterNCT04826042
Effect of Contrast Medium on 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
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. 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?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Mar 2021to 29 Aug 2022
- 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
- gallbladder
Who cannot join
- coagulopathy
- infection
- previous spine fusion at thoracic level
- previous brain lesion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: : 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.
Read the 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.
- Conditions
- Optic Nerve Sheath Diameter
- Being tested
- thoracic epidural catheterization
- Keywords
- optic nerve sheath diameter
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
| Study group | Role | What they receive |
|---|---|---|
| contrast group | Active comparator | injection of contrast medium 6 cc during thoracic epidural catheterization Receives: Other: thoracic epidural catheterization |
| normal saline group | Placebo comparator | injection of normal saline 6 cc during 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 change during 4 time period
optic nerve sheath change during 4 time period using ultrasound
Measured: Baseline, 10 minutes, 20 minutes, 40 minutes after the completion of the intervention
Secondary outcomes (1)
cerebral oxygenation change during 4 time period
cerebral oxygenation change during 4 time period using cerebral oximeter
Measured: Baseline, 10 minutes, 20 minutes, 40 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 posted1 Apr 2021
- Study start29 Mar 2021
- Primary completion29 Aug 2022
- Study completion29 Aug 2022
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
- 42 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826042
- Sponsor's protocol ID
- 2021-01-042
- Status last verified
- Dec 2022
- First submitted
- 29 Mar 2021
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hong JH, Park JH, Park KB. Comparison of Increase in the Optic Nerve Sheath Diameter between Epidural Saline and Contrast Medium Injections. Pain Physician. 2022 Mar;25(2):E263-E269.
PubMed 35322981
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- : Effect of Epidural Injection of Normal Saline or Contrast Medium on Optic Nerve Sheath Diameter
- ClinicalTrials.gov ID
- NCT04826042
- Acronym / sponsor ID
- 2021-01-042
- Conditions
- Optic Nerve Sheath Diameter
- Keywords
- optic nerve sheath diameter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 29 Aug 2022 (actual)
- Study completion
- 29 Aug 2022 (actual)
- First posted
- 1 Apr 2021 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| contrast group | Active comparator | Other: thoracic epidural catheterizationinjection of contrast medium 6 cc during thoracic epidural catheterization |
| normal saline group | Placebo comparator | Other: thoracic epidural catheterizationinjection of normal saline 6 cc during 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 (5 listed)
- lung cancer
- liver cancer
- stomach cancer
- pancreas cancer
- gallbladder
Key exclusion criteria (4 listed)
- coagulopathy
- infection
- previous spine fusion at thoracic level
- previous brain lesion
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 | Other | contrast group, normal saline group |
Primary outcome
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
1 secondary outcome
cerebral oxygenation change during 4 time period
Time frame: Baseline, 10 minutes, 20 minutes, 40 minutes after the completion of the intervention
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 20 Dec 2022.
- Derived from this study: PubMed 35322981Hong JH, Park JH, Park KB. Comparison of Increase in the Optic Nerve Sheath Diameter between Epidural Saline and Contrast Medium Injections. Pain Physician. 2022 Mar;25(2):E263-E269.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 5 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 20 Dec 2022. 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. Some participants in this study may receive a placebo. 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 change during 4 time period (time frame: Baseline, 10 minutes, 20 minutes, 40 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 NCT04826042, 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 20 Dec 2022.