A Randomized Study of the Efficacy of Low Venous Pressure General Anesthesia Versus Combined Spinal-Epidural Anesthesia in Decreasing Blood Loss During Prostate Surgery

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00200187

Run by

Memorial Sloan Kettering Cancer Center

People needed

246

Starts

2005-02-01

Expected to finish

2007-01-01

Last updated by the study team

2007-01-26

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Memorial Sloan-Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.