Optic Nerve Sheath DiameterNCT04758013
Comparison of Changes of ONSD Between Groups of Laparoscopic Surgery With and Without Epidural Saline Injection
A study testing Epidural injection through thoracic epidural catheter and Without epidural injection in people with Optic Nerve Sheath Diameter and Pneumoperitoneum, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
Trial summary
This study targets patients undergoing laparoscopic gastric cancer surgery. The investigators would like to compare two factors that influence intracranial pressure through optic nerve sheath diameter measurement. First factor is intraperitoneal pressure. Second factor is epidural pressure. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Optic Nerve Sheath Diameter, Pneumoperitoneum, Epidural
- What is being tested?
- Epidural injection through thoracic epidural catheter and Without epidural injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Dec 2020to 16 Dec 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gastric surgery due to cancer
Who cannot join
- Coagulopathy
- Infection
- Previous history of thoracic spine surgery
- Ophthalmic diseases
- History of increased Intracranial Pressure
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
KeimyungUniversity
Daegu
JiSeob Kim, 01027487480, demiandew@naver.com
About this study
This study targets patients undergoing laparoscopic gastric cancer surgery.
The investigators would like to compare two factors that influence intracranial pressure through optic nerve sheath diameter measurement.
First factor is intraperitoneal pressure.
Second factor is epidural pressure.
The investigators divided the patients into three groups.
Group A is patients with laparoscopic gastric surgery who received epidural injection through an thoracic epidural catheter.
Group B is patients with laparoscopic gastric surgery who don't received epidural injection through an thoracic epidural catheter.
Group C is patients with open gastric surgery.
- Conditions
- Optic Nerve Sheath Diameter, Pneumoperitoneum, Epidural
- Being tested
- Epidural injection through thoracic epidural catheter, Without epidural injection
- Keywords
- ONSD, pneumoperitoneum, epidural
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural injection through thoracic epidural catheterProcedure or surgery
The investigators inject drugs through a catheter inserted into the thoracic epidural space to control pain after surgery in patients undergoing gastric surgery by laparoscopy.
Without epidural injectionProcedure or surgery
The investigators don't epidural injection to find out the effect of only inter-abdominal pressure on intracranial pressure.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic gastric surgery with Epidural injection | Experimental | Patients with laparoscopic gastric surgery who received epidural injection through an thoracic epidural catheter. Receives: Procedure: Epidural injection through thoracic epidural catheter |
| Laparoscopic gastric surgery without Epidural injection | Experimental | Patients with laparoscopic gastric surgery who don't received epidural injection through an thoracic epidural catheter. Receives: Procedure: Without epidural injection |
| Open gastric surgery | No intervention | Patients with open gastric surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
T0 : Optic nerve sheath diameter
The investigator measures Optic nerve sheath diameter by ultrasonography.
Measured: 10 minutes after anesthesia induction
T1 : Optic nerve sheath diameter
The investigator measures Optic nerve sheath diameter.
Measured: 10min after entering the laparoscope
T2 : Optic nerve sheath diameter
The investigator measures Optic nerve sheath diameter.
Measured: 1hour after entering the laparoscope
T3 : Optic nerve sheath diameter
The investigator measures Optic nerve sheath diameter.
Measured: 10min after the laparoscopy comes out
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start16 Dec 2020
- Primary completion16 Dec 2021 (estimated)
- Study completion16 Dec 2022 (estimated)
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Seob Kim, Keimyung University Dongsan Medical Center
- Investigators
- JiSeob Kim, Principal investigator, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758013
- Sponsor's protocol ID
- KeimyungUniversity
- Status last verified
- Feb 2021
- First submitted
- 8 Feb 2021
- Last updated
- 17 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim JS, Hong JH, Park JH. Comparison of Changes in the Optic Nerve Sheath Diameter Following Thoracic Epidural Normal Saline Injection in Laparoscopic Surgery. Pain Physician. 2022 Jul;25(4):E563-E569.
PubMed 35793180
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Changes of ONSD Between Groups of Laparoscopic Surgery With and Without Epidural Saline Injection
- ClinicalTrials.gov ID
- NCT04758013
- Acronym / sponsor ID
- KeimyungUniversity
- Conditions
- Optic Nerve Sheath Diameter, Pneumoperitoneum, Epidural
- Keywords
- ONSD, pneumoperitoneum, epidural
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 16 Dec 2021 (estimated)
- Study completion
- 16 Dec 2022 (estimated)
- First posted
- 17 Feb 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.
This study targets patients undergoing laparoscopic gastric cancer surgery.
The investigators would like to compare two factors that influence intracranial pressure through optic nerve sheath diameter measurement.
First factor is intraperitoneal pressure.
Second factor is epidural pressure.
The investigators divided the patients into three groups.
Group A is patients with laparoscopic gastric surgery who received epidural injection through an thoracic epidural catheter.
Group B is patients with laparoscopic gastric surgery who don't received epidural injection through an thoracic epidural catheter.
Group C is patients with open gastric surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic gastric surgery with Epidural injection | Experimental | Procedure: Epidural injection through thoracic epidural catheterPatients with laparoscopic gastric surgery who received epidural injection through an thoracic epidural catheter. |
| Laparoscopic gastric surgery without Epidural injection | Experimental | Procedure: Without epidural injectionPatients with laparoscopic gastric surgery who don't received epidural injection through an thoracic epidural catheter. |
| Open gastric surgery | No intervention | –Patients with open gastric surgery. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Gastric surgery due to cancer
Key exclusion criteria (5 listed)
- Coagulopathy
- Infection
- Previous history of thoracic spine surgery
- Ophthalmic diseases
- History of 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 |
|---|---|---|
| Epidural injection through thoracic epidural catheterThe investigators inject drugs through a catheter inserted into the thoracic epidural space to control pain after surgery in patients undergoing gastric surgery by laparoscopy. | Procedure or surgery | Laparoscopic gastric surgery with Epidural injection |
| Without epidural injectionThe investigators don't epidural injection to find out the effect of only inter-abdominal pressure on intracranial pressure. | Procedure or surgery | Laparoscopic gastric surgery without Epidural injection |
Primary outcome
T0 : Optic nerve sheath diameter
Time frame: 10 minutes after anesthesia induction
The investigator measures Optic nerve sheath diameter by ultrasonography.
T1 : Optic nerve sheath diameter
Time frame: 10min after entering the laparoscope
The investigator measures Optic nerve sheath diameter.
T2 : Optic nerve sheath diameter
Time frame: 1hour after entering the laparoscope
The investigator measures Optic nerve sheath diameter.
T3 : Optic nerve sheath diameter
Time frame: 10min after the laparoscopy comes out
The investigator measures Optic nerve sheath diameter.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Derived from this study: PubMed 35793180Kim JS, Hong JH, Park JH. Comparison of Changes in the Optic Nerve Sheath Diameter Following Thoracic Epidural Normal Saline Injection in Laparoscopic Surgery. Pain Physician. 2022 Jul;25(4):E563-E569.
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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.
JiSeob Kim principal investigator
Keimyung University Dongsan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural injection through thoracic epidural catheter and Without epidural injection in people with Optic Nerve Sheath Diameter and Pneumoperitoneum, 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JiSeob Kim (01027487480, demiandew@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T0 : Optic nerve sheath diameter (time frame: 10 minutes after anesthesia induction). The study lists 4 primary outcomes in all. 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 NCT04758013, 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 17 Feb 2021.