Robot-Assisted Laparoscopic Radical ProstatectomyNCT02109133
The Impacts of Surgical Visibility Through Deep Neuromuscular Blockade on Intraocular Pressure in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy
A study testing deep neuromuscular blockade, moderate neuromuscular blockade and Rocuronium in people with Robot-Assisted Laparoscopic Radical Prostatectomy, run by Yonsei University at 1 site in South Korea.
Trial summary
Intraocular pressure is significantly increase during robot-assisted laparoscopic radical prostatectomy which is performed in a steep trendelenburg position at prolonged times of pneumoperitoneum. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Robot-Assisted Laparoscopic Radical Prostatectomy
- What is being tested?
- deep neuromuscular blockade, moderate neuromuscular blockade and Rocuronium
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA class I-II
- obtaining written informed consent from the parents
- aged over 50 years who were undergoing robot- assisted laparoscopic prostatectomy
Who cannot join
- eye surgery previously
- unstable angina or congestive heart failure
- concomitant eye disease (glaucoma, diabetic retinopathy, cataract, retinal detachment)
- high intraocular pressure over 30mmHg after screening test.
- uncontrolled hypertension (diastolic bp>110mmHg)
- coagulopathy
Show all 16Show fewer
- asthma
- hepatic failure
- renal failure(creatinine clearance < 30 ml/min)
- drug hyperactivity
- neurological or psychiatric illnesses
- mental retardation
- patients who can't read the consent form due to illiterate or foreigner
- previous malignant hyperthermia Hx
- drug medication which interact with muscle relaxant (anti-convulsant, certain antibiotics, magnesium etc)
- BMI > 30kg/m2
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, Seoul, 120-752
About this study
Intraocular pressure is significantly increase during robot-assisted laparoscopic radical prostatectomy which is performed in a steep trendelenburg position at prolonged times of pneumoperitoneum. Therefore investigators decided to evaluate the impacts of surgical visibility through deep neuromuscular blockade on intraocular pressure in patients undergoing Robot-Assisted Laparoscopic Radical Prostatectomy.
- Being tested
- deep neuromuscular blockade, moderate neuromuscular blockade, Rocuronium, Sugammadex, Atracurium
- Keywords
- deep neuromuscular blockade, intraocular pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep neuromuscular blockadeProcedure or surgery
deep neuromuscular blockade using rocuronium and reverse with sugammadex
moderate neuromuscular blockadeProcedure or surgery
moderate neuromuscular blockade using atracurium and reverse with neostigmine
RocuroniumDrug
SugammadexDrug
AtracuriumDrug
NeostigmineDrug
| Study group | Role | What they receive |
|---|---|---|
| Deep neuromuscular blockade | Experimental | Deep neuromuscular blockade Receives: Procedure: deep neuromuscular blockade; Drug: Rocuronium; Drug: Sugammadex |
| moderate neuromuscular blockade | Active comparator | moderate neuromuscular blockade Receives: Procedure: moderate neuromuscular blockade; Drug: Atracurium; Drug: Neostigmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Intraocular Pressure During RALRP Under Deep Neuromuscular Blockade
maximum intraocular pressure during RALRP under deep neuromuscular blockade after being positioned in the steep Trendelenburg position with CO2 pneumoperitoneum under deep neuromuscular blockade
Measured: Maximum intraocular pressure was measured at 60 minutes after CO2 pneumoperitoneum in the ST position
Secondary outcomes (1)
Overall Surgical Condition
overall surgical conditions using the 5-point rating scale as previously described: Grade 5 (optimal), optimal surgical conditions; grade 4 (good), nonoptimal conditions, but an intervention is not required; grade 3 (acceptable), wide surgical view, but an intervention can improve surgical conditions, grade 2 (poor), inadequate conditions, there is a visible view, but an intervention is necessary to ensure acceptable surgical conditions; grade 1 (extremely poor), inability to perform surgery; therefore, intervention is necessary.
Measured: At the end of the Steep trendelenburg position, an average of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Robot-Assisted Laparoscopic Radical ProstatectomyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02109133
- Sponsor's protocol ID
- 4-2014-0058
- Status last verified
- Jun 2015
- First submitted
- 30 Mar 2014
- Last updated
- 24 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Yoo YC, Kim NY, Shin S, Choi YD, Hong JH, Kim CY, Park H, Bai SJ. The Intraocular Pressure under Deep versus Moderate Neuromuscular Blockade during Low-Pressure Robot Assisted Laparoscopic Radical Prostatectomy in a Randomized Trial. PLoS One. 2015 Aug 28;10(8):e0135412. doi: 10.1371/journal.pone.0135412. eCollection 2015.
PubMed 26317357
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impacts of Surgical Visibility Through Deep Neuromuscular Blockade on Intraocular Pressure in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT02109133
- Acronym / sponsor ID
- 4-2014-0058
- Keywords
- deep neuromuscular blockade, intraocular pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Apr 2014 (estimated)
- Results
- Posted 24 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intraocular pressure is significantly increase during robot-assisted laparoscopic radical prostatectomy which is performed in a steep trendelenburg position at prolonged times of pneumoperitoneum. Therefore investigators decided to evaluate the impacts of surgical visibility through deep neuromuscular blockade on intraocular pressure in patients undergoing Robot-Assisted Laparoscopic Radical Prostatectomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep neuromuscular blockade | Experimental | Procedure: deep neuromuscular blockade, Drug: Rocuronium, Drug: SugammadexDeep neuromuscular blockade |
| moderate neuromuscular blockade | Active comparator | Procedure: moderate neuromuscular blockade, Drug: Atracurium, Drug: Neostigminemoderate neuromuscular blockade |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA class I-II
- obtaining written informed consent from the parents
- aged over 50 years who were undergoing robot- assisted laparoscopic prostatectomy
Key exclusion criteria (16 listed)
- eye surgery previously
- unstable angina or congestive heart failure
- concomitant eye disease (glaucoma, diabetic retinopathy, cataract, retinal detachment)
- high intraocular pressure over 30mmHg after screening test.
- uncontrolled hypertension (diastolic bp>110mmHg)
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 |
|---|---|---|
| deep neuromuscular blockadedeep neuromuscular blockade using rocuronium and reverse with sugammadex | Procedure or surgery | Deep neuromuscular blockade |
| moderate neuromuscular blockademoderate neuromuscular blockade using atracurium and reverse with neostigmine | Procedure or surgery | moderate neuromuscular blockade |
| Rocuronium | Drug | Deep neuromuscular blockade |
| Sugammadex | Drug | Deep neuromuscular blockade |
| Atracurium | Drug | moderate neuromuscular blockade |
| Neostigmine | Drug | moderate neuromuscular blockade |
Primary outcome
Maximum Intraocular Pressure During RALRP Under Deep Neuromuscular Blockade
Time frame: Maximum intraocular pressure was measured at 60 minutes after CO2 pneumoperitoneum in the ST position
maximum intraocular pressure during RALRP under deep neuromuscular blockade after being positioned in the steep Trendelenburg position with CO2 pneumoperitoneum under deep neuromuscular blockade
1 secondary outcome
Overall Surgical Condition
Time frame: At the end of the Steep trendelenburg position, an average of 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26317357Yoo YC, Kim NY, Shin S, Choi YD, Hong JH, Kim CY, Park H, Bai SJ. The Intraocular Pressure under Deep versus Moderate Neuromuscular Blockade during Low-Pressure Robot Assisted Laparoscopic Radical Prostatectomy in a Randomized Trial. PLoS One. 2015 Aug 28;10(8):e0135412. doi: 10.1371/journal.pone.0135412. eCollection 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing deep neuromuscular blockade, moderate neuromuscular blockade and Rocuronium in people with Robot-Assisted Laparoscopic Radical Prostatectomy, run by Yonsei University 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 16 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 24 Jun 2015. 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?
Yes. Results are posted in the registry (first posted 24 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximum Intraocular Pressure During RALRP Under Deep Neuromuscular Blockade (time frame: Maximum intraocular pressure was measured at 60 minutes after CO2 pneumoperitoneum in the ST 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 NCT02109133, 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 24 Jun 2015.