Status:
COMPLETED
A Randomized Study of the Efficacy of Low Venous Pressure General Anesthesia Versus Combined Spinal-Epidural Anesthesia in Decreasing Blood Loss During Prostate Surgery
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 type...
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 b...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
246 Patients enrolled
Trial Details
Trial ID
NCT00200187
Start Date
February 1 2005
End Date
January 1 2007
Last Update
January 26 2007
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021