Prostate CancerNCT02402621
Comparison Between Conventional and Model-based Infusion Strategy of IV PCA in Patients Undergoing RALP
A study testing fentanyl in people with Prostate Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Comparing postoperative analgesics requirements and complications between conventional and model-based infusion strategy of intravenous patient-controlled analgesia in patients who undergoing robot assisted laparoscopic radical prostatectomy Group A: conventional intravenous patient-controlled analgesia, Group B… Read more about this study
- Who is it for?
- Ages 20 to 69 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2015to Sep 2015
- 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 69 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who is scheduled to get a robot assisted laparoscopic radical prostatectomy
- Patient who agree to get a patient controlled analgesia
Who cannot join
- American Society of Anesthesiologist (ASA) physical status over III
- History of alcohol or drug addiction
- History of acute or chronic pain or pain treatment
- Allergic to opioid analgesics
- BMI over 30 kg/m2
- History of sleep apnea or respiratory complications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Conventional and Model-based Infusion Strategy of Intravenous Patient-controlled Analgesia in Patients Undergoing Robot Assisted Laparoscopic Radical Prostatectomy
Comparing postoperative analgesics requirements and complications between conventional and model-based infusion strategy of intravenous patient-controlled analgesia in patients who undergoing robot assisted laparoscopic radical prostatectomy
Group A: conventional intravenous patient-controlled analgesia, Group B: model-based infusion strategy of intravenous patient-controlled analgesia
Read the detailed description
The investigators compared postoperative analgesics requirements and complications between conventional and model-based infusion strategy of intravenous patient-controlled analgesia (IV PCA) in patients who undergoing robot assisted laparoscopic radical prostatectomy (RALP)
Group A: conventional IV PCA, Group B: model based IV PCA
- Primary endpoint: comparison of postoperative analgesic requirements in patient undergoing robot assisted laparoscopic radical prostatectomy (RALP) between conventional patient controlled analgesia (PCA) (Group A) and effective-compartment based dosing strategy of PCA (Group B)
- Secondary endpoint: 1) VAS analysis between two groups, 2) postoperative nausea and vomiting analysis between two groups, 3) complication evaluation between two groups
- Conditions
- Prostate Cancer
- Being tested
- fentanyl
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fentanylDrug
fentanyl with antiemetic drug
| Study group | Role | What they receive |
|---|---|---|
| Conventional analgesic group | Active comparator | fentanyl Receives: Drug: fentanyl |
| Model based analgesic group | Experimental | fentanyl Receives: Drug: fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount and number of postoperative analgesic requirements
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Secondary outcomes (4)
Number of participants with complications
Measured: Up to 48 hours
Visual Analog Scale (VAS)
Measured: Up to 48 hours
Postoperative nausea and vomiting
Measured: Up to 48 hours
Respiratory rate, oxygen saturation
Measured: Up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionSep 2015
- Study completionSep 2015
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 111 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, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02402621
- Sponsor's protocol ID
- 2015-0267
- Status last verified
- Nov 2015
- First submitted
- 23 Mar 2015
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Conventional and Model-based Infusion Strategy of Intravenous Patient-controlled Analgesia in Patients Undergoing Robot Assisted Laparoscopic Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT02402621
- Acronym / sponsor ID
- 2015-0267
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 30 Mar 2015 (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.
Comparing postoperative analgesics requirements and complications between conventional and model-based infusion strategy of intravenous patient-controlled analgesia in patients who undergoing robot assisted laparoscopic radical prostatectomy
Group A: conventional intravenous patient-controlled analgesia, Group B: model-based infusion strategy of intravenous patient-controlled analgesia
Detailed description
The investigators compared postoperative analgesics requirements and complications between conventional and model-based infusion strategy of intravenous patient-controlled analgesia (IV PCA) in patients who undergoing robot assisted laparoscopic radical prostatectomy (RALP)
Group A: conventional IV PCA, Group B: model based IV PCA
- Primary endpoint: comparison of postoperative analgesic requirements in patient undergoing robot assisted laparoscopic radical prostatectomy (RALP) between conventional patient controlled analgesia (PCA) (Group A) and effective-compartment based dosing strategy of PCA (Group B)
- Secondary endpoint: 1) VAS analysis between two groups, 2) postoperative nausea and vomiting analysis between two groups, 3) complication evaluation between two groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional analgesic group | Active comparator | Drug: fentanylfentanyl |
| Model based analgesic group | Experimental | Drug: fentanylfentanyl |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient who is scheduled to get a robot assisted laparoscopic radical prostatectomy
- Patient who agree to get a patient controlled analgesia
Key exclusion criteria (6 listed)
- American Society of Anesthesiologist (ASA) physical status over III
- History of alcohol or drug addiction
- History of acute or chronic pain or pain treatment
- Allergic to opioid analgesics
- BMI over 30 kg/m2
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 |
|---|---|---|
| fentanylfentanyl with antiemetic drug | Drug | Conventional analgesic group, Model based analgesic group |
Primary outcome
Amount and number of postoperative analgesic requirements
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
4 secondary outcomes
Number of participants with complications
Time frame: Up to 48 hours
Visual Analog Scale (VAS)
Time frame: Up to 48 hours
Postoperative nausea and vomiting
Time frame: Up to 48 hours
Respiratory rate, oxygen saturation
Time frame: Up to 48 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 2 Dec 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.
Young-Kug Kim 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 fentanyl 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 2 inclusion and 6 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 2 Dec 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?
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?
Amount and number of postoperative analgesic requirements (time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week). 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 2 Dec 2015.