Prostate CancerNCT03271502
Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
A study testing Total intravenous anesthesia and Inhalation anesthesia in people with Prostate Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study was to evaluate the difference between the optic nerve sheath diameter measured during total intravenous anesthesia and the optic nerve sheath diameter measured during inhalation anesthesia in patients undergoing robot-assisted laparoscopic prostatectomy. 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?
- Total intravenous anesthesia and Inhalation anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Sep 2017to 1 Oct 2017
- 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 79 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have undergone a robot-assisted laparoscopic prostatectomy with a prostate cancer and who are 20 years of age or older and under 80 years of age and who agree to participate in this study.
Who cannot join
- Patients with a history of cerebral hemorrhage or cerebral infarction, Patients < 20 years of age, Patients ≥ 80 years of age, Patients with unexpected hemodynamic instability during surgery, Failure to measure optic nerve sheath diameter.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Inhalation Anesthesia With Sevoflurane and Total Intravenous Anesthesia With Propofol on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
The purpose of this study was to evaluate the difference between the optic nerve sheath diameter measured during total intravenous anesthesia and the optic nerve sheath diameter measured during inhalation anesthesia in patients undergoing robot-assisted laparoscopic prostatectomy.
Read the detailed description
The purpose of this study was to evaluate the difference between the optic nerve sheath diameter measured during total intravenous anesthesia with propofol and remifentanil and the optic nerve sheath diameter measured during inhalation anesthesia with sevoflurane and remifentanil in patients undergoing robot-assisted laparoscopic prostatectomy.
- Conditions
- Prostate Cancer
- Being tested
- Total intravenous anesthesia, Inhalation anesthesia
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total intravenous anesthesiaProcedure or surgery
Total intravenous anesthesia with propofol and remifentanil
Inhalation anesthesiaProcedure or surgery
Inhalation anesthesia with sevoflurane and remifentanil
| Study group | Role | What they receive |
|---|---|---|
| Total intravenous anesthesia | Experimental | Total intravenous anesthesia with propofol and remifentanil Receives: Procedure: Total intravenous anesthesia |
| Inhalation anesthesia | Active comparator | Inhalation anesthesia with sevoflurane and remifentanil Receives: Procedure: Inhalation anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in optic nerve sheath diameter
Difference between the optic nerve sheath diameter measured during total intravenous anesthesia and the optic nerve sheath diameter measured during inhalation anesthesia
Measured: 60 minutes after pneumoperitoneum and steep Trendelenburg position
Secondary outcomes (2)
Difference in optic nerve sheath diameter
Difference between the optic nerve sheath diameter measured during total intravenous anesthesia and the optic nerve sheath diameter measured during inhalation anesthesia
Measured: 30 minutes after pneumoperitoneum and steep Trendelenburg position
Difference in optic nerve sheath diameter
Difference between the optic nerve sheath diameter measured during total intravenous anesthesia and the optic nerve sheath diameter measured during inhalation anesthesia
Measured: 5 minutes after pneumoperitoneum and steep Trendelenburg position
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start4 Sep 2017
- Primary completion26 Sep 2017
- Study completion1 Oct 2017
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
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
- NCT03271502
- Sponsor's protocol ID
- 2017-1011
- Status last verified
- Oct 2017
- First submitted
- 31 Aug 2017
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yu J, Hong JH, Park JY, Hwang JH, Cho SS, Kim YK. Propofol attenuates the increase of sonographic optic nerve sheath diameter during robot-assisted laparoscopic prostatectomy: a randomized clinical trial. BMC Anesthesiol. 2018 Jun 20;18(1):72. doi: 10.1186/s12871-018-0523-7.
PubMed 29925316
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Inhalation Anesthesia With Sevoflurane and Total Intravenous Anesthesia With Propofol on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
- ClinicalTrials.gov ID
- NCT03271502
- Acronym / sponsor ID
- 2017-1011
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 4 Sep 2017 (actual)
- Primary completion
- 26 Sep 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 5 Sep 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.
The purpose of this study was to evaluate the difference between the optic nerve sheath diameter measured during total intravenous anesthesia and the optic nerve sheath diameter measured during inhalation anesthesia in patients undergoing robot-assisted laparoscopic prostatectomy.
Detailed description
The purpose of this study was to evaluate the difference between the optic nerve sheath diameter measured during total intravenous anesthesia with propofol and remifentanil and the optic nerve sheath diameter measured during inhalation anesthesia with sevoflurane and remifentanil in patients undergoing robot-assisted laparoscopic prostatectomy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total intravenous anesthesia | Experimental | Procedure: Total intravenous anesthesiaTotal intravenous anesthesia with propofol and remifentanil |
| Inhalation anesthesia | Active comparator | Procedure: Inhalation anesthesiaInhalation anesthesia with sevoflurane and remifentanil |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have undergone a robot-assisted laparoscopic prostatectomy with a prostate cancer and who are 20 years of age or older and under 80 years of age and who agree to participate in this study.
Key exclusion criteria (1 listed)
- Patients with a history of cerebral hemorrhage or cerebral infarction, Patients < 20 years of age, Patients ≥ 80 years of age, Patients with unexpected hemodynamic instability during surgery, Failure to measure optic nerve sheath diameter.
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 |
|---|---|---|
| Total intravenous anesthesiaTotal intravenous anesthesia with propofol and remifentanil | Procedure or surgery | Total intravenous anesthesia |
| Inhalation anesthesiaInhalation anesthesia with sevoflurane and remifentanil | Procedure or surgery | Inhalation anesthesia |
Primary outcome
Difference in optic nerve sheath diameter
Time frame: 60 minutes after pneumoperitoneum and steep Trendelenburg position
Difference between the optic nerve sheath diameter measured during total intravenous anesthesia and the optic nerve sheath diameter measured during inhalation anesthesia
2 secondary outcomes
Difference in optic nerve sheath diameter
Time frame: 30 minutes after pneumoperitoneum and steep Trendelenburg position
Difference in optic nerve sheath diameter
Time frame: 5 minutes after pneumoperitoneum and steep Trendelenburg position
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 26 Oct 2017.
- Derived from this study: PubMed 29925316Yu J, Hong JH, Park JY, Hwang JH, Cho SS, Kim YK. Propofol attenuates the increase of sonographic optic nerve sheath diameter during robot-assisted laparoscopic prostatectomy: a randomized clinical trial. BMC Anesthesiol. 2018 Jun 20;18(1):72. doi: 10.1186/s12871-018-0523-7.
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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?
A study testing Total intravenous anesthesia and Inhalation anesthesia in people with 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 1 inclusion and 1 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 26 Oct 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?
Difference in optic nerve sheath diameter (time frame: 60 minutes after pneumoperitoneum and steep Trendelenburg position). 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 NCT03271502, 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 26 Oct 2017.