Prostate CancerNCT03214055
Effect of Mannitol on Optic Nerve Sheath Diameter in Patients Undergoing Robotic Prostatectomy
An observational study of Prostate Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial summary
We aim to evaluate the change in optic nerve sheath diameters as a surrogate of intracranial pressure before and after mannitol administration in patients who undergo robot assisted laparoscopic radical prostatectomy with pneumoperitoneum and Trendelenburg position. Read more about this study
- Who is it for?
- Ages 20 to 79 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Mannitol
- How many people
- 39 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jul 2017to 20 Aug 2017
- How long will I take part?
- 7 Days
- Phase
- Observational
- 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 79 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Prostate cancer patients who undergo Robot-assisted laparoscopic radical prostatectomy.
Who may be able to join
- prostate cancer patients undergoing robot assisted laparoscopic radical prostatectomy.
- 20 year old or above, 79 year old or below.
- agreed to participate this study.
Who cannot join
- history of cerebrovascular accident.
- history of congestive heart failure.
- history of pulmonary edema.
- history of anaphylaxis to mannitol.
- conversion to open prostatectomy.
- combined with other operation.
- inability to measure optic nerve sheath diameter.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Mannitol on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Radical Prostatectomy: a Prospective Observational Study
We aim to evaluate the change in optic nerve sheath diameters as a surrogate of intracranial pressure before and after mannitol administration in patients who undergo robot assisted laparoscopic radical prostatectomy with pneumoperitoneum and Trendelenburg position.
Read the detailed description
Mannitol has been frequently used for renal protection during surgery. Optic nerve sheath diameter is used to evaluate intracranial pressure noninvasively. Robot-assisted laparoscopic radical prostatectomy can induce an increase in optic nerve sheath diameter due to Trendelenburg position and carbon dioxide insufflation. We therefore aim to evaluate the change in optic nerve sheath diameters before and after mannitol administration in patients who undergo robot assisted laparoscopic radical prostatectomy.
- Conditions
- Prostate Cancer
- Being tested
- Mannitol
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MannitolDrug
Also called Osmotic diuretic
The mannitol has been administered routinely to prevent renal dysfunction in patients undergoing robot-assisted laparoscopic radical prostatectomy. Participants will receive the mannitol as part of routine medical care, and we will evaluate the change in optic nerve sheath diameters before and after mannitol administration.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in optic nerve sheath diameters
Change in optic nerve sheath diameters before and after mannitol administration
Measured: 5 minutes after pneumoperitoneum and Trendelenburg position, 90 minutes after mannitol administration during pneumoperitoneum and Trendelenburg position
Secondary outcomes (4)
Change in optic nerve sheath diameters
Change in optic nerve sheath diameters before and after mannitol administration
Measured: 5 minutes after pneumoperitoneum and Trendelenburg position, 60 minutes after mannitol administration during pneumoperitoneum and Trendelenburg position
Change in optic nerve sheath diameters
Change in optic nerve sheath diameters before and after mannitol administration
Measured: 5 minutes after pneumoperitoneum and Trendelenburg position, 30 minutes after mannitol administration during pneumoperitoneum and Trendelenburg position
Optic nerve sheath diameter
Optic nerve sheath diameter before mannitol administration
Measured: 10 minutes after induction of anesthesia
Optic nerve sheath diameter
Optic nerve sheath diameter after mannitol administration
Measured: Intraoperative (during skin closure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start12 Jul 2017
- Primary completion14 Aug 2017
- Study completion20 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young-Kug Kim, Asan Medical Center
- Investigators
- Young-Kug Kim, MD,PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214055
- Sponsor's protocol ID
- 2017-0789
- Status last verified
- Aug 2017
- First submitted
- 7 Jul 2017
- Last updated
- 25 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mannitol on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Radical Prostatectomy: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03214055
- Acronym / sponsor ID
- 2017-0789
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 12 Jul 2017 (actual)
- Primary completion
- 14 Aug 2017 (actual)
- Study completion
- 20 Aug 2017 (actual)
- First posted
- 11 Jul 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.
We aim to evaluate the change in optic nerve sheath diameters as a surrogate of intracranial pressure before and after mannitol administration in patients who undergo robot assisted laparoscopic radical prostatectomy with pneumoperitoneum and Trendelenburg position.
Detailed description
Mannitol has been frequently used for renal protection during surgery. Optic nerve sheath diameter is used to evaluate intracranial pressure noninvasively. Robot-assisted laparoscopic radical prostatectomy can induce an increase in optic nerve sheath diameter due to Trendelenburg position and carbon dioxide insufflation. We therefore aim to evaluate the change in optic nerve sheath diameters before and after mannitol administration in patients who undergo robot assisted laparoscopic radical prostatectomy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 7 Days
Who may qualify
- Ages
- 20 to 79 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prostate cancer patients who undergo Robot-assisted laparoscopic radical prostatectomy.
Key inclusion criteria (3 listed)
- prostate cancer patients undergoing robot assisted laparoscopic radical prostatectomy.
- 20 year old or above, 79 year old or below.
- agreed to participate this study.
Key exclusion criteria (7 listed)
- history of cerebrovascular accident.
- history of congestive heart failure.
- history of pulmonary edema.
- history of anaphylaxis to mannitol.
- conversion to open prostatectomy.
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 |
|---|---|---|
| MannitolAlso: Osmotic diureticThe mannitol has been administered routinely to prevent renal dysfunction in patients undergoing robot-assisted laparoscopic radical prostatectomy. Participants will receive the mannitol as part of routine medical care, and we will evaluate the change in optic nerve sheath diameters before and after mannitol administration. | Drug | – |
Primary outcome
Change in optic nerve sheath diameters
Time frame: 5 minutes after pneumoperitoneum and Trendelenburg position, 90 minutes after mannitol administration during pneumoperitoneum and Trendelenburg position
Change in optic nerve sheath diameters before and after mannitol administration
4 secondary outcomes
Change in optic nerve sheath diameters
Time frame: 5 minutes after pneumoperitoneum and Trendelenburg position, 60 minutes after mannitol administration during pneumoperitoneum and Trendelenburg position
Change in optic nerve sheath diameters
Time frame: 5 minutes after pneumoperitoneum and Trendelenburg position, 30 minutes after mannitol administration during pneumoperitoneum and Trendelenburg position
Optic nerve sheath diameter
Time frame: 10 minutes after induction of anesthesia
Optic nerve sheath diameter
Time frame: Intraoperative (during skin closure)
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 25 Aug 2017.
- 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.
Young-Kug Kim, MD,PhD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Asan 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 3 inclusion and 7 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 25 Aug 2017. 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?
Change in optic nerve sheath diameters (time frame: 5 minutes after pneumoperitoneum and Trendelenburg position, 90 minutes after mannitol administration during pneumoperitoneum and Trendelenburg position). 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 25 Aug 2017.