A Randomized Study of the Efficacy of Low Venous Pressure General Anesthesia Versus Combined Spin… (NCT00200187) | Clinical Trial Compass
CompletedPhase 2
A Randomized Study of the Efficacy of Low Venous Pressure General Anesthesia Versus Combined Spinal-Epidural Anesthesia in Decreasing Blood Loss During Prostate Surgery
United States246 participantsStarted 2005-02
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 transure…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Aim #1: To determine whether LVPGA reduces blood loss by >= 300 ml versus CSE in patients undergoing open RRP
2
Aim #2: To compare transfusion rates of autologous and allogenic blood between the two anesthesia groups
3
Aim #3: To identify differences in pattern of blood loss in the two groups according to different surgical stages
4
Stage I: Pelvic Lymph node dissection: From skin incision to completion of pelvic node dissection
5
Stage II: Prostatectomy: From endopelvic fascia opening to completion of prostatic bed hemostasis after the prostate is removed
6
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)
7
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