Prostate CancerNCT02041559
The Effect of Different Doses of Remifentanil on Kidney Function During Robot Assisted Prostatectomy - A Retrospective Study
An observational study of Prostate Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
Robot assisted prostatectomy reduces the patients' postoperative pain and leads to rapid rehabilitation. But pneumoperitoneum affects the kidney. The increase of stress hormone reduces the glomerular filtration and the vaso-contraction of renal vessels leads the renal ischemia. Read more about this study
- Who is it for?
- Ages 20 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 1,500 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2014to Dec 2014
- 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 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: male patients undergoing robot assisted prostatectomy
Who may be able to join
- ages > 19 years and < 85 years
- the patients undergoing a general anesthesia for robot assisted prostatectomy
Who cannot join
- incomplete record
- history of opioid or steroid using
- solitary kidney
- history of kidney transplantation
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System
Seoul, 120-752
Ji Eun Kim, MD, 82-2-2019-6808, beye98@yuhs.ac
About this study
Robot assisted prostatectomy reduces the patients' postoperative pain and leads to rapid rehabilitation. But pneumoperitoneum affects the kidney. The increase of stress hormone reduces the glomerular filtration and the vaso-contraction of renal vessels leads the renal ischemia. Remifentanil is analgesics coupled with μ opioid receptor. In high dose of remifentanil, it is associated with κ and δ receptors, which leads to renal protection effect in animal study. Also, remifentanil infusion during anesthesia showed a diuretic effect. The purpose of this study is to investigate the remifentanil effect on renal function during robot assisted prostatectomy.
- Conditions
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| robot assisted prostatectomy | robot assisted prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute kidney injury incidence based on Acute Kidney Injury Network criteria
Acute kidney injury incidence based on Acute Kidney Injury Network criteria was defined as increase in serum creatinine from baseline of ≥ 0.3 mg/dl within a 48-hour period. Acute kidney injury is evaluated at POD 1.
Measured: 24 hours after end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041559
- Sponsor's protocol ID
- 4-2013-0753
- Status last verified
- Jan 2014
- First submitted
- 13 Jan 2014
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Doses of Remifentanil on Kidney Function During Robot Assisted Prostatectomy - A Retrospective Study
- ClinicalTrials.gov ID
- NCT02041559
- Acronym / sponsor ID
- 4-2013-0753
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 22 Jan 2014 (estimated)
- 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.
Robot assisted prostatectomy reduces the patients' postoperative pain and leads to rapid rehabilitation. But pneumoperitoneum affects the kidney. The increase of stress hormone reduces the glomerular filtration and the vaso-contraction of renal vessels leads the renal ischemia. Remifentanil is analgesics coupled with μ opioid receptor. In high dose of remifentanil, it is associated with κ and δ receptors, which leads to renal protection effect in animal study. Also, remifentanil infusion during anesthesia showed a diuretic effect. The purpose of this study is to investigate the remifentanil effect on renal function during robot assisted prostatectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| robot assisted prostatectomy | – | –robot assisted prostatectomy |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- male patients undergoing robot assisted prostatectomy
Key inclusion criteria (2 listed)
- ages > 19 years and < 85 years
- the patients undergoing a general anesthesia for robot assisted prostatectomy
Key exclusion criteria (4 listed)
- incomplete record
- history of opioid or steroid using
- solitary kidney
- history of kidney transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
acute kidney injury incidence based on Acute Kidney Injury Network criteria
Time frame: 24 hours after end of surgery
Acute kidney injury incidence based on Acute Kidney Injury Network criteria was defined as increase in serum creatinine from baseline of ≥ 0.3 mg/dl within a 48-hour period. Acute kidney injury is evaluated at POD 1.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
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 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 Jan 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ji Eun Kim, MD (82-2-2019-6808, beye98@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute kidney injury incidence based on Acute Kidney Injury Network criteria (time frame: 24 hours after end of surgery). 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 22 Jan 2014.