Prostatic CancerNCT01086956
Effect of Adding Sufentanil to Epidural Ropivacaine on Perioperative Metabolic and Stress Responses in Combined General/Epidural Anaesthesia for Geriatric Radical Retropubic Prostatectomy
A study testing epidural infusion of saline, ropivecaine, or ropivacaine and sufentanil in people with Prostatic Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to compare metabolic and stress responses in combined general/epidural anesthesia in geriatric cancer patients. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Prostatic Cancer
- What is being tested?
- epidural infusion of saline, ropivecaine, or ropivacaine and sufentanil
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2008to Dec 2009
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- elective RRP for prostatic cancer scheduled in the morning (9-11 a.m.)
- patients aged more than 65 years
- ASA physical status I or II
- absence of contraindications to epidural approach
- absence of a history of chronic pain or opioid medication
Who cannot join
- contraindication to epidural catheterization
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare metabolic and stress responses in combined general/epidural anesthesia in geriatric cancer patients.
- Conditions
- Prostatic Cancer
- Being tested
- epidural infusion of saline, ropivecaine, or ropivacaine and sufentanil
- Keywords
- patients of prostatic cancer aged more than 65 years
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidural infusion of saline, ropivecaine, or ropivacaine and sufentanilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma glucose, insulin, cortisol, epinephrine, norepinephrine, prolactin
Measured: from preoperative baseline to postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2010 (estimated)
- Study startSep 2008
- Primary completionDec 2009
- Study completionDec 2009
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 Prostatic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01086956
- Sponsor's protocol ID
- 4-2008-0319
- Status last verified
- Nov 2010
- First submitted
- 12 Mar 2010
- Last updated
- 11 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Hong JY, Yang SC, Yi J, Kil HK. Epidural ropivacaine and sufentanil and the perioperative stress response after a radical retropubic prostatectomy. Acta Anaesthesiol Scand. 2011 Mar;55(3):282-9. doi: 10.1111/j.1399-6576.2010.02360.x. Epub 2010 Nov 25.
PubMed 21108620
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Sufentanil to Epidural Ropivacaine on Perioperative Metabolic and Stress Responses in Combined General/Epidural Anaesthesia for Geriatric Radical Retropubic Prostatectomy
- ClinicalTrials.gov ID
- NCT01086956
- Acronym / sponsor ID
- 4-2008-0319
- Conditions
- Prostatic Cancer
- Keywords
- patients of prostatic cancer aged more than 65 years
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 15 Mar 2010 (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.
The purpose of this study is to compare metabolic and stress responses in combined general/epidural anesthesia in geriatric cancer patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- elective RRP for prostatic cancer scheduled in the morning (9-11 a.m.)
- patients aged more than 65 years
- ASA physical status I or II
- absence of contraindications to epidural approach
- absence of a history of chronic pain or opioid medication
Key exclusion criteria (1 listed)
- contraindication to epidural catheterization
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 |
|---|---|---|
| epidural infusion of saline, ropivecaine, or ropivacaine and sufentanil | Drug | – |
Primary outcome
plasma glucose, insulin, cortisol, epinephrine, norepinephrine, prolactin
Time frame: from preoperative baseline to postoperative 24 hours
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 11 Nov 2010.
- Derived from this study: PubMed 21108620Hong JY, Yang SC, Yi J, Kil HK. Epidural ropivacaine and sufentanil and the perioperative stress response after a radical retropubic prostatectomy. Acta Anaesthesiol Scand. 2011 Mar;55(3):282-9. doi: 10.1111/j.1399-6576.2010.02360.x. Epub 2010 Nov 25.
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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 epidural infusion of saline, ropivecaine, or ropivacaine and sufentanil in people with Prostatic 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 5 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 11 Nov 2010. 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?
plasma glucose, insulin, cortisol, epinephrine, norepinephrine, prolactin (time frame: from preoperative baseline to postoperative 24 hours). 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 NCT01086956, 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 11 Nov 2010.