Optic Nerve Sheath DiameterNCT04339244
Effect of Pressure Regulation on Optic Nerve Sheath Diameter
A study testing RALRP under lower mean BP in people with Optic Nerve Sheath Diameter, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
Trial summary
Intracranial pressure is known to increase during robot-assisted laparoscopic radical prostatectomy (RALRP) due to steep trendelenberg position. Measurement of optic nerve sheath diameter (ONSD) is a indirect method which can assess the degree of intracranial pressure. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Optic Nerve Sheath Diameter
- What is being tested?
- RALRP under lower mean BP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2020to 15 Sep 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prostate cancer receiving RALRP
Who cannot join
- glaucoma
- intracranial tumor
- previous disease elevating intracranial pressure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Arterial Pressure Regulation on Optic Nerve Sheath Diameter During Robot Assisted Laparoscopic Surgery
Intracranial pressure is known to increase during robot-assisted laparoscopic radical prostatectomy (RALRP) due to steep trendelenberg position. Measurement of optic nerve sheath diameter (ONSD) is a indirect method which can assess the degree of intracranial pressure.
This study is designed to measure the ONSD during RALRP under regulation of arterial pressure.
Read the detailed description
During last decades, RALRP has been advocated due to the advantages of short hospital stay, reduced blood loss during surgery, less postoperative pain and complication. During RALRP, steep trendelenberg postion and pneumoperitoneum are required essentially, and this is for the acquisition of adequite surgical field. However, such position and pneumoperitoneum can result in harmful hemodynamic change. Previous study demonstrated that patients of RALRP showed 12.5% increase of ONSD.
The relationship of ONSD and increase of intracranial pressure has been proved previously through many studies. Recent meta analysis showed that ONSD measurement for the monitor of ICP demonstrated that sensitivity 0.9, specificity 0.85 and ROC cuve 0.983.
In addition, increase of ONSD during RALRP can be affected by the degree of arterial pressure and end tidal CO2 increase.
This study is designed to see the effect of arterial pressure regulation on the increase of ONSD
- Conditions
- Optic Nerve Sheath Diameter
- Being tested
- RALRP under lower mean BP
- Keywords
- arterial pressure regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RALRP under lower mean BPOther
RALRP under regulation of lower mean BP
RALRP under lower mean BPOther
RALRP under regulation of highly normal mean BP
| Study group | Role | What they receive |
|---|---|---|
| ONSD measurement under lower blood pressure | Active comparator | ONSD measurement under mean blood pressure of 60~70 mmHg Receives: Other: RALRP under lower mean BP |
| ONSD measurement under highly normal blood pressure | Active comparator | ONSD measurement under mean blood pressure of 90~100 mmHg Receives: Other: RALRP under lower mean BP |
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
optice nerve sheath diameter change among 4 time period
Measured: Baseline, 1 hour, 2 hours, 2.5 hours after 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 posted9 Apr 2020
- Study start1 Apr 2020
- Primary completion15 Aug 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 51 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
- Sung Won Jung, PhD, Study director, 82532584892
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04339244
- Sponsor's protocol ID
- 2019-07-049
- Status last verified
- Oct 2020
- First submitted
- 6 Apr 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Arterial Pressure Regulation on Optic Nerve Sheath Diameter During Robot Assisted Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT04339244
- Acronym / sponsor ID
- 2019-07-049
- Conditions
- Optic Nerve Sheath Diameter
- Keywords
- arterial pressure regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 9 Apr 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.
Intracranial pressure is known to increase during robot-assisted laparoscopic radical prostatectomy (RALRP) due to steep trendelenberg position. Measurement of optic nerve sheath diameter (ONSD) is a indirect method which can assess the degree of intracranial pressure.
This study is designed to measure the ONSD during RALRP under regulation of arterial pressure.
Detailed description
During last decades, RALRP has been advocated due to the advantages of short hospital stay, reduced blood loss during surgery, less postoperative pain and complication. During RALRP, steep trendelenberg postion and pneumoperitoneum are required essentially, and this is for the acquisition of adequite surgical field. However, such position and pneumoperitoneum can result in harmful hemodynamic change. Previous study demonstrated that patients of RALRP showed 12.5% increase of ONSD.
The relationship of ONSD and increase of intracranial pressure has been proved previously through many studies. Recent meta analysis showed that ONSD measurement for the monitor of ICP demonstrated that sensitivity 0.9, specificity 0.85 and ROC cuve 0.983.
In addition, increase of ONSD during RALRP can be affected by the degree of arterial pressure and end tidal CO2 increase.
This study is designed to see the effect of arterial pressure regulation on the increase of ONSD
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ONSD measurement under lower blood pressure | Active comparator | Other: RALRP under lower mean BPONSD measurement under mean blood pressure of 60~70 mmHg |
| ONSD measurement under highly normal blood pressure | Active comparator | Other: RALRP under lower mean BPONSD measurement under mean blood pressure of 90~100 mmHg |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Prostate cancer receiving RALRP
Key exclusion criteria (3 listed)
- glaucoma
- intracranial tumor
- previous disease elevating 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 |
|---|---|---|
| RALRP under lower mean BPRALRP under regulation of lower mean BP | Other | ONSD measurement under lower blood pressure |
| RALRP under lower mean BPRALRP under regulation of highly normal mean BP | Other | ONSD measurement under highly normal blood pressure |
Primary outcome
optic nerve sheath diameter change among 4 time period
Time frame: Baseline, 1 hour, 2 hours, 2.5 hours after completion of the intervention
optice nerve sheath diameter change among 4 time period
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 14 Oct 2020.
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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.
Sung Won Jung, PhD study director
82532584892
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RALRP under lower mean BP 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 1 inclusion and 3 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 14 Oct 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 diameter change among 4 time period (time frame: Baseline, 1 hour, 2 hours, 2.5 hours after completion of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2020.