Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00200187
Status:
COMPLETED
Last Update Posted:
2007-01-26
First Post:
2005-09-12
Brief Title:
A Randomized Study of the Efficacy of Low Venous Pressure General Anesthesia Versus Combined Spinal-Epidural Anesthesia in Decreasing Blood Loss During Prostate Surgery
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 80 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 MorbidityMortality 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 IV 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None