Prostate Cancer
Conditions
Keywords
prostate cancer, robotic surgery, muscle relaxants, neuromuscular blockade, 18-408, Memorial Sloan Kettering Cancer Center
Brief summary
The purpose of this study is to determine if there is a difference in intra-abdominal pressure which surgeons use during surgery and post-surgery pain in men who undergo robotic prostate surgery with deep neuromuscular blockade (NMB), compared with moderate NMB.
Interventions
DRUGRocuronium 0.3mg/kg/hr
The Moderate NMB group (Control ) will have rocuronium infusion titrated to moderate paralysis defined as TOF of 1-2 (infusion start rate 0.003 mg/kg/min or 0.18mg/kg/hr).
DRUGRocuronium 1.5mg/kg/hr
The Deep NMB group (Intervention) will have rocuronium infusion titrated to deep paralysis defined as PTC of 1-2 (infusion start rate 0.006mg/kg/min or 0.35mg/kg/hr).
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients under the age of 80 * American Society of Anesthesiologists Physical Status 1, 2, 3. * Elective Robotic Prostatectomy * Patient undergoing surgery at Josie Robertson Surgical Center
Exclusion criteria
* Age younger than 18 * Inability to provide informed consent * Allergy to rocuronium, sugammadex, midazolam, propofol, fentanyl, lidocaine, mannitol (IV Acetaeminophen), IV Acetaminophen, Ketorolac, Morphine, Hydromorphone, Dexamethasone, Zofran, Benadryl, Compazine * Neuromuscular disease * Any patient with previous abdominal surgery less than or equal to 20 years prior to scheduled surgery date * Patients with BMI\>35 * Severe renal impairment (Creatinine clearance \< 30 ml/min) * Patient receiving Toremifene or any history of receiving Toremifene * Chronic pain patients * Patients receiving suboxone * Patients receiving succinylcholine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Difference in Intra-Abdominal Pressure (IAP) When Performing Robotic Prostatectomy in Participants Under a Moderate vs Deep Neuromuscular Blockade Technique | 6 hours post operation | Measured by continuous Intra-abdominal Pressure monitor in mmHg. |
| Difference in Levels of Postoperative Pain in Participants Under a Moderate vs Deep Neuromuscular Blockade Technique During Robotic Prostatectomy Using the Pain Numeric Pain Scale (NPS). | 6 hours post operation | Difference in levels of postoperative pain in participants under a moderate vs deep Neuromuscular Blockade technique during robotic prostatectomy using the pain numeric pain scale (NPS). The numeric pain scale (NPS) is a subjective measure which can be used in recovery rooms to assist in the assessment of pain. Individuals rate their pain on an eleven-point scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORElizabeth Rieth, MD
Memorial Sloan Kettering Cancer Center
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Interventional Group: Deep Neuromuscular Blockade The Deep NMB group (Intervention) will have rocuronium infusion titrated to deep paralysis defined as PTC of 1-2 (infusion start rate 0.025mg/kg/min or 1.5mg/kg/hr).
Rocuronium 1.5mg/kg/hr: The Deep NMB group (Intervention) will have rocuronium infusion titrated to deep paralysis defined as PTC of 1-2 (infusion start rate 0.006mg/kg/min or 0.35mg/kg/hr). | 72 |
| Control Group: Moderate Neuromuscular Blockade The Moderate NMB group (Control ) will have rocuronium infusion titrated to moderate paralysis defined as TOF of 1-2 (infusion start rate 0.005mg/kg/min or 0.3mg/kg/hr).
Rocuronium 0.3mg/kg/hr: The Moderate NMB group (Control ) will have rocuronium infusion titrated to moderate paralysis defined as TOF of 1-2 (infusion start rate 0.003 mg/kg/min or 0.18mg/kg/hr). | 67 |
| Total | 139 |
Baseline characteristics
| Characteristic | Interventional Group: Deep Neuromuscular Blockade | Total | Control Group: Moderate Neuromuscular Blockade |
|---|---|---|---|
| Age, Continuous | 63 years | 63 years | 63 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 8 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 68 Participants | 127 Participants | 59 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 20 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) White | 60 Participants | 112 Participants | 52 Participants |
| Region of Enrollment United States | 72 Participants | 139 Participants | 67 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 72 Participants | 139 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 72 | 0 / 67 |
| other Total, other adverse events | 0 / 72 | 0 / 67 |
| serious Total, serious adverse events | 1 / 72 | 0 / 67 |
Outcome results
Primary
Difference in Levels of Postoperative Pain in Participants Under a Moderate vs Deep Neuromuscular Blockade Technique During Robotic Prostatectomy Using the Pain Numeric Pain Scale (NPS).
Difference in levels of postoperative pain in participants under a moderate vs deep Neuromuscular Blockade technique during robotic prostatectomy using the pain numeric pain scale (NPS). The numeric pain scale (NPS) is a subjective measure which can be used in recovery rooms to assist in the assessment of pain. Individuals rate their pain on an eleven-point scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Time frame: 6 hours post operation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Interventional Group: Deep Neuromuscular Blockade | Difference in Levels of Postoperative Pain in Participants Under a Moderate vs Deep Neuromuscular Blockade Technique During Robotic Prostatectomy Using the Pain Numeric Pain Scale (NPS). | 3.25 score on a scale |
| Control Group: Moderate Neuromuscular Blockade | Difference in Levels of Postoperative Pain in Participants Under a Moderate vs Deep Neuromuscular Blockade Technique During Robotic Prostatectomy Using the Pain Numeric Pain Scale (NPS). | 3.41 score on a scale |
Primary
Mean Difference in Intra-Abdominal Pressure (IAP) When Performing Robotic Prostatectomy in Participants Under a Moderate vs Deep Neuromuscular Blockade Technique
Measured by continuous Intra-abdominal Pressure monitor in mmHg.
Time frame: 6 hours post operation
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Interventional Group: Deep Neuromuscular Blockade | Mean Difference in Intra-Abdominal Pressure (IAP) When Performing Robotic Prostatectomy in Participants Under a Moderate vs Deep Neuromuscular Blockade Technique | 10.50 mmHg |
| Control Group: Moderate Neuromuscular Blockade | Mean Difference in Intra-Abdominal Pressure (IAP) When Performing Robotic Prostatectomy in Participants Under a Moderate vs Deep Neuromuscular Blockade Technique | 11.41 mmHg |