Prostate CancerPhase 2NCT00200187
A Randomized Study of the Efficacy of Low Venous Pressure General Anesthesia Versus Combined Spinal-Epidural Anesthesia in Decreasing Blood Loss During Prostate Surgery
A Phase 2 study testing low venous pressure general anesthesia and combined spinal-epidural anesthesia in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
You are being asked to join the study because you have early stage prostate cancer and will have your prostate removed. The purpose of this study is to compare blood loss during surgery among two types of anesthesia. One type is general anesthesia. It puts you in a deep enough sleep that you will not feel anything. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- low venous pressure general anesthesia and combined spinal-epidural anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 246 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Jan 2007
- Phase
- Phase 2
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- They are scheduled for RRP by Drs. Scardino or Eastham.
- They speak English in order to cooperate during CSE if randomized to such arm.
- They have clinically localized disease, clinical stage < cT3NxM0 (1997 TNM), any Gleason grade
- Must be willing to receive blood products or blood if deemed clinically necessary
- Must be willing to receive epidural or general anesthesia
- All subjects must be age 18 or older
- Patient or the patient's legally acceptable representative must sign and date informed consent PRIOR to any study related procedures being performed.
- Patient must have an MRI of the prostate done at MSKCC prior to RRP.
Who cannot join
- Prior history of significant cardiac disease (defined as unstable angina, coronary artery stent placement within 8 weeks of surgery, MI within 6 months of surgery, known history of cardiomyopathy, congestive heart failure or significant valvular heart disease), insulin dependent diabetes mellitus, or clinically significant carotid artery disease.
- Presence of renal insufficiency (define by creatinine level > 1.6 mg/dl).
- Prior radiation therapy to the pelvis or prostate
- History of bleeding tendencies, hemorrhagic diathesis, or known primary or secondary hematological disease such as chronic renal failure, Von Willebrand disease, and thrombocytopenia among others.
- History of lumbar spine disease or peripheral neurological conditions that may contraindicate use of CSE anesthesia.
- Prior transurethral resection of the prostate or a suprapubic prostatectomy
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- Prior history of an abdominal perineal resection or local excision of a colorectal cancer
- Patients requiring anticoagulation due to a pre-existing medical illness or increased risk for thromboembolic events such as prior history of pulmonary embolus, morbid obesity, atrial fibrillation, mechanical heart valve, etc.
- History of morphine allergy
- History of fentanyl allergy
- History of allergy to local anesthetics
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: A Randomized Study of the Efficacy of Low Venous Pressure General Anesthesia Versus Combined Spinal-Epidural Anesthesia in Decreasing Blood Loss During Radical Retropubic Prostatectomy
You are being asked to join the study because you have early stage prostate cancer and will have your prostate removed. The purpose of this study is to compare blood loss during surgery among two types of anesthesia. One type is general anesthesia. It puts you in a deep enough sleep that you will not feel anything. It also keeps your blood pressure low, which might decrease bleeding. The second type is combined spinal-epidural anesthesia. For this type, a small catheter is placed in your spinal canal through your back. Anesthesia given through the catheter makes your body numb from the waist down, so the sleep you would be in is not so deep. Your blood pressure would remain in your normal range. After surgery, the catheter remains in place to treat your pain, but your body would not be numb. When you wake up after general anesthesia, you would receive pain medicine through a vein in your arm.
Both types are used at Memorial Hospital. They are accepted forms of anesthesia. We will be looking at blood loss between these two types for patients having their prostate removed. We also want to learn about the side effects of each anesthesia type, and assess pain that you experience after surgery.
Read the detailed description
This is a prospective randomized trial comparing the efficacy of a low venous pressure general anesthesia (LVPGA) technique vs. combined spinal-epidural anesthesia (CSE) in decreasing intraoperative blood loss in patients undergoing open radical retropubic prostatectomy (RRP) for newly diagnosed clinically localized adenocarcinoma of the prostate. The study design involves the enrollment of 246 patients scheduled for RRP. To control for surgeon technique in the varibility of intraoperative blood loss, the study will be limited to the patient population of two surgeons who perform greater than 150 radical prostatectomies per year. Patients will be stratified for each surgeon and will be randomized to receive either a LVPGA or CSE. Preoperatively patients will be encouraged to donate autologous blood as is the current practice at MSKCC. Perioperative measurement and management of fluid administration, estimation of blood loss and urine output, and transfusion criteria will be standardized for both anesthesia groups. Transfusion of blood products will be at the discretion of the attending surgeon and anesthesiologist following the guidelines described in the protocol. Autologous blood will not routinely be transfused back if the hemoglobin is >= 8.0 and the patient is not symptomatic. Patients randomized to the CSE arm will also receive postoperative epidural analgesia, while patients randomized to LVPGA will receive intravenous PCA analgesia as per our current standard of care. Pain relief will be assessed by a standardized pain scale and recorded in the PACU and then twice daily until discharge. All patients will receive routine preoperative evaluation, as well as routine intraoperative and postoperative monitoring and care. All patients will be placed on a routine postoperative pathway. The MSKCC Morbidity/Mortality DMT Documentation System will be utilized to document postoperative complications as per our routine practice. The Surgical Secondary Events (SSE) program is designed to provide risk adjusted postoperative morbidity and mortality data for institutional comparisons and as a decision support project, generating, reporting and analyzing events to promote change and improvement in patient management. SSE are grouped in 6 grades depending on the severity of the complication and the treatment requirements: Grade 0, no event observed beyond 30 days postop. Grade 1, use of oral medications, bedside interventions to treat an event. Grade 2, use of I.V. medications, TPN, enteral nutrition, or blood transfusion to treat an event. Grade 3, interventional radiology, therapeutic endoscopy, intubation, angiography or operation required to treat an event. Grade 4, residual and lasting disability requiring major rehabilitation or organ resection. Grade 5, event resulting in death of patient.
- Conditions
- Prostate Cancer
- Being tested
- low venous pressure general anesthesia, combined spinal-epidural anesthesia
- Keywords
- Prostatectomy, Anesthesia, Blood Loss
- Medical subject headings
- Prostatic Neoplasms, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low venous pressure general anesthesiaProcedure or surgery
combined spinal-epidural anesthesiaProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim #1: To determine whether LVPGA reduces blood loss by >= 300 ml versus CSE in patients undergoing open RRP
Aim #2: To compare transfusion rates of autologous and allogenic blood between the two anesthesia groups
Aim #3: To identify differences in pattern of blood loss in the two groups according to different surgical stages
Stage I: Pelvic Lymph node dissection: From skin incision to completion of pelvic node dissection
Stage II: Prostatectomy: From endopelvic fascia opening to completion of prostatic bed hemostasis after the prostate is removed
Stage II a: Dorsal venous complex control: From endopelvic fascia opening to beginning of nerve bundles dissection (or ligature in case they were not preserved)
Stage II b: Nerve bundles dissection and prostate removal: From the beginning of nerve bundles dissection to completion of prostatic bed hemostasis after the prostate is removed
Stage III: Urinary tract reconstruction: From bladder neck reconstruction to completion of skin closure
Secondary outcomes (4)
To compare postoperative complication type, incidence and grade experienced by the two groups. The current MSKCC morbidity and mortality definitions and grading system will be utilized
To compare the efficacy of pain control postoperatively in the two groups (epidural PCA versus intravenous PCA+ NSAID's)
To compare length of hospital stay for the two groups
To prospectively evaluate the relationship of pelvimetry, urethral length and prostatic veins size on MRI 1 to intraoperative blood loss and complications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startFeb 2005
- Study completionJan 2007
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 Memorial Sloan Kettering Cancer 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 246 participants
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Sherri M Donat, MD, FACS, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200187
- Sponsor's protocol ID
- 05-003
- Status last verified
- Jan 2007
- First submitted
- 12 Sep 2005
- Last updated
- 26 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of the Efficacy of Low Venous Pressure General Anesthesia Versus Combined Spinal-Epidural Anesthesia in Decreasing Blood Loss During Radical Retropubic Prostatectomy
- ClinicalTrials.gov ID
- NCT00200187
- Acronym / sponsor ID
- 05-003
- Conditions
- Prostate Cancer
- Keywords
- Prostatectomy, Anesthesia, Blood Loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Feb 2005
- Study completion
- Jan 2007
- First posted
- 20 Sep 2005 (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.
You are being asked to join the study because you have early stage prostate cancer and will have your prostate removed. The purpose of this study is to compare blood loss during surgery among two types of anesthesia. One type is general anesthesia. It puts you in a deep enough sleep that you will not feel anything. It also keeps your blood pressure low, which might decrease bleeding. The second type is combined spinal-epidural anesthesia. For this type, a small catheter is placed in your spinal canal through your back. Anesthesia given through the catheter makes your body numb from the waist down, so the sleep you would be in is not so deep. Your blood pressure would remain in your normal range. After surgery, the catheter remains in place to treat your pain, but your body would not be numb. When you wake up after general anesthesia, you would receive pain medicine through a vein in your arm.
Both types are used at Memorial Hospital. They are accepted forms of anesthesia. We will be looking at blood loss between these two types for patients having their prostate removed. We also want to learn about the side effects of each anesthesia type, and assess pain that you experience after surgery.
Detailed description
This is a prospective randomized trial comparing the efficacy of a low venous pressure general anesthesia (LVPGA) technique vs. combined spinal-epidural anesthesia (CSE) in decreasing intraoperative blood loss in patients undergoing open radical retropubic prostatectomy (RRP) for newly diagnosed clinically localized adenocarcinoma of the prostate. The study design involves the enrollment of 246 patients scheduled for RRP. To control for surgeon technique in the varibility of intraoperative blood loss, the study will be limited to the patient population of two surgeons who perform greater than 150 radical prostatectomies per year. Patients will be stratified for each surgeon and will be randomized to receive either a LVPGA or CSE. Preoperatively patients will be encouraged to donate autologous blood as is the current practice at MSKCC. Perioperative measurement and management of fluid administration, estimation of blood loss and urine output, and transfusion criteria will be standardized for both anesthesia groups. Transfusion of blood products will be at the discretion of the attending surgeon and anesthesiologist following the guidelines described in the protocol. Autologous blood will not routinely be transfused back if the hemoglobin is >= 8.0 and the patient is not symptomatic. Patients randomized to the CSE arm will also receive postoperative epidural analgesia, while patients randomized to LVPGA will receive intravenous PCA analgesia as per our current standard of care. Pain relief will be assessed by a standardized pain scale and recorded in the PACU and then twice daily until discharge. All patients will receive routine preoperative evaluation, as well as routine intraoperative and postoperative monitoring and care. All patients will be placed on a routine postoperative pathway. The MSKCC Morbidity/Mortality DMT Documentation System will be utilized to document postoperative complications as per our routine practice. The Surgical Secondary Events (SSE) program is designed to provide risk adjusted postoperative morbidity and mortality data for institutional comparisons and as a decision support project, generating, reporting and analyzing events to promote change and improvement in patient management. SSE are grouped in 6 grades depending on the severity of the complication and the treatment requirements: Grade 0, no event observed beyond 30 days postop. Grade 1, use of oral medications, bedside interventions to treat an event. Grade 2, use of I.V. medications, TPN, enteral nutrition, or blood transfusion to treat an event. Grade 3, interventional radiology, therapeutic endoscopy, intubation, angiography or operation required to treat an event. Grade 4, residual and lasting disability requiring major rehabilitation or organ resection. Grade 5, event resulting in death of patient.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- They are scheduled for RRP by Drs. Scardino or Eastham.
- They speak English in order to cooperate during CSE if randomized to such arm.
- They have clinically localized disease, clinical stage < cT3NxM0 (1997 TNM), any Gleason grade
- Must be willing to receive blood products or blood if deemed clinically necessary
- Must be willing to receive epidural or general anesthesia
Key exclusion criteria (11 listed)
- Prior history of significant cardiac disease (defined as unstable angina, coronary artery stent placement within 8 weeks of surgery, MI within 6 months of surgery, known history of cardiomyopathy, congestive heart failure or significant valvular heart disease), insulin dependent diabetes mellitus, or clinically significant carotid artery disease.
- Presence of renal insufficiency (define by creatinine level > 1.6 mg/dl).
- Prior radiation therapy to the pelvis or prostate
- History of bleeding tendencies, hemorrhagic diathesis, or known primary or secondary hematological disease such as chronic renal failure, Von Willebrand disease, and thrombocytopenia among others.
- History of lumbar spine disease or peripheral neurological conditions that may contraindicate use of CSE anesthesia.
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 |
|---|---|---|
| low venous pressure general anesthesia | Procedure or surgery | – |
| combined spinal-epidural anesthesia | Procedure or surgery | – |
Primary outcome
Aim #1: To determine whether LVPGA reduces blood loss by >= 300 ml versus CSE in patients undergoing open RRP
Aim #2: To compare transfusion rates of autologous and allogenic blood between the two anesthesia groups
Aim #3: To identify differences in pattern of blood loss in the two groups according to different surgical stages
Stage I: Pelvic Lymph node dissection: From skin incision to completion of pelvic node dissection
Stage II: Prostatectomy: From endopelvic fascia opening to completion of prostatic bed hemostasis after the prostate is removed
Stage II a: Dorsal venous complex control: From endopelvic fascia opening to beginning of nerve bundles dissection (or ligature in case they were not preserved)
Stage II b: Nerve bundles dissection and prostate removal: From the beginning of nerve bundles dissection to completion of prostatic bed hemostasis after the prostate is removed
Stage III: Urinary tract reconstruction: From bladder neck reconstruction to completion of skin closure
4 secondary outcomes
To compare postoperative complication type, incidence and grade experienced by the two groups. The current MSKCC morbidity and mortality definitions and grading system will be utilized
To compare the efficacy of pain control postoperatively in the two groups (epidural PCA versus intravenous PCA+ NSAID's)
To compare length of hospital stay for the two groups
To prospectively evaluate the relationship of pelvimetry, urethral length and prostatic veins size on MRI 1 to intraoperative blood loss and complications
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 26 Jan 2007.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
Sherri M Donat, MD, FACS principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing low venous pressure general anesthesia and combined spinal-epidural anesthesia in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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 8 inclusion and 11 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 26 Jan 2007. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Aim #1: To determine whether LVPGA reduces blood loss by >= 300 ml versus CSE in patients undergoing open RRP. The study lists 8 primary outcomes in all. 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 26 Jan 2007.