Optic Nerve Sheath DiameterNCT04412109
Optic Nerve Sheath Diameter Difference Between Different Injection Volume
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
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. 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, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 May 2020to 16 Nov 2020
- 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 cancer
Who cannot join
- coagulopathy
- infection
- previous spine fusion at thoracic level
- previous brain lesion causing increased intracranial pressure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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 different volume of normal saline was injected.
- Conditions
- Optic Nerve Sheath Diameter
- Being tested
- thoracic epidural catheterization
- Keywords
- Optic Nerve Sheath Diameter, Different volume
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracic epidural catheterizationProcedure or surgery
thoracic epidural catheterization for postoperative pain control
| Study group | Role | What they receive |
|---|---|---|
| injection of low volume of saline | Active comparator | low volume (5 cc) saline injection during thoracic epidural catheterization Receives: Procedure: thoracic epidural catheterization |
| injection of intermediate volume of saline | Active comparator | intermediate volume (10 cc) saline injection during thoracic epidural catheterization Receives: Procedure: thoracic epidural catheterization |
| injection of high volume of saline | Active comparator | high volume (20 cc) saline injection during thoracic epidural catheterization Receives: Procedure: 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 pressure monitoring kit
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 posted2 Jun 2020
- Study start25 May 2020
- Primary completion16 Nov 2020
- Study completion16 Nov 2020
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
- 50 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
- NCT04412109
- Sponsor's protocol ID
- 2020-01-081
- Status last verified
- Nov 2020
- First submitted
- 28 May 2020
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hong J, Kim JS, Lee YH. The Effect of Normal Saline Injection Volumes on the Optic Nerve Sheath Diameter during Thoracic Epidural Analgesia. Pain Physician. 2021 Nov;24(7):E1007-E1013.
PubMed 34704711
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Normal Saline Injection Volume on Epidural Pressure and Optic Nerve Sheath Diameter
- ClinicalTrials.gov ID
- NCT04412109
- Acronym / sponsor ID
- 2020-01-081
- Conditions
- Optic Nerve Sheath Diameter
- Keywords
- Optic Nerve Sheath Diameter, Different volume
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 25 May 2020 (actual)
- Primary completion
- 16 Nov 2020 (actual)
- Study completion
- 16 Nov 2020 (actual)
- First posted
- 2 Jun 2020 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| injection of low volume of saline | Active comparator | Procedure: thoracic epidural catheterizationlow volume (5 cc) saline injection during thoracic epidural catheterization |
| injection of intermediate volume of saline | Active comparator | Procedure: thoracic epidural catheterizationintermediate volume (10 cc) saline injection during thoracic epidural catheterization |
| injection of high volume of saline | Active comparator | Procedure: thoracic epidural catheterizationhigh volume (20 cc) saline injection 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 cancer
Key exclusion criteria (4 listed)
- coagulopathy
- infection
- previous spine fusion at thoracic level
- previous brain lesion causing increased intracranial pressure
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 for postoperative pain control | Procedure or surgery | injection of high volume of saline, injection of intermediate volume of saline, injection of low volume of saline |
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 18 Nov 2020.
- Derived from this study: PubMed 34704711Hong J, Kim JS, Lee YH. The Effect of Normal Saline Injection Volumes on the Optic Nerve Sheath Diameter during Thoracic Epidural Analgesia. Pain Physician. 2021 Nov;24(7):E1007-E1013.
- 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 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 18 Nov 2020. 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 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 NCT04412109, 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 18 Nov 2020.