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
18 Years
N/A
Male
Prostate Cancer
Trial Information
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
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.
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 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Aim #1: To determine whether LVPGA reduces blood loss by >= 300 ml versus CSE in patients undergoing open RRP
Principal Investigator
Sherri M Donat, MD, FACS
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
05-003
NCT ID:
NCT00200187
Start Date:
February 2005
Completion Date:
January 2007
Related Keywords:
- Prostate Cancer
- Prostatectomy
- Anesthesia
- Blood Loss
- Hemorrhage
- Prostatic Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
