Prostate CancerNCT03529643
Effect of Anesthetic Method on Optic Nerve Sheath Diameter in Patients Undergoing RALP
A study testing Dexmedetomidine and Without dexmedetomidine 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 effect of anesthetic method on the optic nerve sheath diameter 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?
- Dexmedetomidine and Without dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 May 2018to 22 Aug 2018
- 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
- Undergone a robot-assisted laparoscopic prostatectomy with a prostate - cancer
- 20 years of age or older and under 80 years of age
- Agree to participate in this study
Who cannot join
- History of cerebral hemorrhage or cerebral infarction
- < 20 years of age
- ≥ 80 years of age
- Glaucoma
- Unexpected hemodynamic instability during surgery
- Failure to measure optic nerve sheath diameter
- Convert to open surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Anesthetic Method on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy: Comparison of Sevoflurane-remifentanil and Sevoflurane-remifentanil-dexmedetomidine
The purpose of this study was to evaluate the effect of anesthetic method on the optic nerve sheath diameter 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 anesthesia with sevoflurane-remifentanil-dexmedetomidine and the optic nerve sheath diameter measured during anesthesia with sevoflurane-remifentanil in patients undergoing robot-assisted laparoscopic prostatectomy.
- Conditions
- Prostate Cancer
- Being tested
- Dexmedetomidine, Without dexmedetomidine
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called With Dexmedetomidine
Anesthesia with sevoflurane-remifentanil-dexmedetomidine
Without dexmedetomidineOther
Also called With normal saline
Anesthesia with sevoflurane-remifentanil
| Study group | Role | What they receive |
|---|---|---|
| Anesthesia with dexmedetomidine | Experimental | Anesthesia with sevoflurane-remifentanil-dexmedetomidine
Dexmedetomidine :Continuous infusion of dexmedetomidine with loading dose of 1.0 μg/kg (0.25 ml/kg) for 10 minutes, then followed by maintenance dose of 0.4 µg/kg/hr (0.1 ml/kg/hr). Receives: Drug: Dexmedetomidine |
| Anesthesia without dexmedetomidine | Placebo comparator | Anesthesia with sevoflurane-remifentanil
Normal saline :Continuous infusion of normal saline with loading dose (0.25 ml/kg) for 10 minutes, then followed by maintenance dose (0.1 ml/kg/hr). Receives: Other: Without dexmedetomidine |
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 anesthesia with sevoflurane-remifentanil-dexmedetomidine and the optic nerve sheath diameter measured during anesthesia with sevoflurane-remifentanil in patients undergoing robot-assisted laparoscopic prostatectomy
Measured: 60 minutes after pneumoperitoneum and steep Trendelenburg position
Secondary outcomes (3)
Difference in optic nerve sheath diameter
Difference between the optic nerve sheath diameter measured during anesthesia with sevoflurane-remifentanil-dexmedetomidine and the optic nerve sheath diameter measured during anesthesia with sevoflurane-remifentanil in patients undergoing robot-assisted laparoscopic prostatectomy.
Measured: 30 minutes after pneumoperitoneum and steep Trendelenburg position
Difference in optic nerve sheath diameter
Difference between the optic nerve sheath diameter measured during anesthesia with sevoflurane-remifentanil-dexmedetomidine and the optic nerve sheath diameter measured during anesthesia with sevoflurane-remifentanil in patients undergoing robot-assisted laparoscopic prostatectomy
Measured: 10 minutes after anesthesia induction
Difference in optic nerve sheath diameter
Difference between the optic nerve sheath diameter measured during anesthesia with sevoflurane-remifentanil-dexmedetomidine and the optic nerve sheath diameter measured during anesthesia with sevoflurane-remifentanil in patients undergoing robot-assisted laparoscopic prostatectomy
Measured: At skin closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start24 May 2018
- Primary completion16 Aug 2018
- Study completion22 Aug 2018
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
- 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
- 128 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
- NCT03529643
- Sponsor's protocol ID
- 20180523
- Status last verified
- Sep 2018
- First submitted
- 8 May 2018
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anesthetic Method on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy: Comparison of Sevoflurane-remifentanil and Sevoflurane-remifentanil-dexmedetomidine
- ClinicalTrials.gov ID
- NCT03529643
- Acronym / sponsor ID
- 20180523
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 24 May 2018 (actual)
- Primary completion
- 16 Aug 2018 (actual)
- Study completion
- 22 Aug 2018 (actual)
- First posted
- 18 May 2018 (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 effect of anesthetic method on the optic nerve sheath diameter 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 anesthesia with sevoflurane-remifentanil-dexmedetomidine and the optic nerve sheath diameter measured during anesthesia with sevoflurane-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 |
|---|---|---|
| Anesthesia with dexmedetomidine | Experimental | Drug: DexmedetomidineAnesthesia with sevoflurane-remifentanil-dexmedetomidine Dexmedetomidine :Continuous infusion of dexmedetomidine with loading dose of 1.0 μg/kg (0.25 ml/kg) for 10 minutes, then followed by maintenance dose of 0.4 µg/kg/hr (0.1 ml/kg/hr). |
| Anesthesia without dexmedetomidine | Placebo comparator | Other: Without dexmedetomidineAnesthesia with sevoflurane-remifentanil Normal saline :Continuous infusion of normal saline with loading dose (0.25 ml/kg) for 10 minutes, then followed by maintenance dose (0.1 ml/kg/hr). |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Undergone a robot-assisted laparoscopic prostatectomy with a prostate - cancer
- 20 years of age or older and under 80 years of age
- Agree to participate in this study
Key exclusion criteria (7 listed)
- History of cerebral hemorrhage or cerebral infarction
- < 20 years of age
- ≥ 80 years of age
- Glaucoma
- Unexpected hemodynamic instability during surgery
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 |
|---|---|---|
| DexmedetomidineAlso: With DexmedetomidineAnesthesia with sevoflurane-remifentanil-dexmedetomidine | Drug | Anesthesia with dexmedetomidine |
| Without dexmedetomidineAlso: With normal salineAnesthesia with sevoflurane-remifentanil | Other | Anesthesia without dexmedetomidine |
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 anesthesia with sevoflurane-remifentanil-dexmedetomidine and the optic nerve sheath diameter measured during anesthesia with sevoflurane-remifentanil in patients undergoing robot-assisted laparoscopic prostatectomy
3 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: 10 minutes after anesthesia induction
Difference in optic nerve sheath diameter
Time frame: At 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 13 Sep 2018.
- 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?
A study testing Dexmedetomidine and Without dexmedetomidine 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 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 13 Sep 2018. 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. Some participants in this study may receive a placebo. 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?
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 13 Sep 2018.