A Randomized Controlled Trial to Compare the Effectiveness of Deep vs. Moderate Neuromuscular Blockade in Reducing Postoperative Pain and Intra-Abdominal Insufflation Pressure During Minimally Invasive Robotic Prostatectomy
Overview
- Phase
- Phase 2
- Intervention
- Rocuronium 1.5mg/kg/hr
- Conditions
- Prostate Cancer
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 139
- Locations
- 1
- Primary Endpoint
- Mean Difference in Intra-Abdominal Pressure (IAP) When Performing Robotic Prostatectomy in Participants Under a Moderate vs Deep Neuromuscular Blockade Technique
- Status
- Active, not recruiting
- Last Updated
- last month
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult patients under the age of 80
- •American Society of Anesthesiologists Physical Status 1, 2,
- •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
Arms & Interventions
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).
Intervention: Rocuronium 1.5mg/kg/hr
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).
Intervention: Rocuronium 0.3mg/kg/hr
Outcomes
Primary Outcomes
Mean Difference in Intra-Abdominal Pressure (IAP) When Performing Robotic Prostatectomy in Participants Under a Moderate vs Deep Neuromuscular Blockade Technique
Time Frame: 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).
Time Frame: 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).