The Effect of Deep Versus Moderate Muscle Relaxants in Men During and After Robotic Surgery for Prostate Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Rocuronium 0.3mg/kg/hr
* Drug: Rocuronium 1.5mg/kg/hr


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional Group: Deep Neuromuscular Blockade<br>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). | Drug: Rocuronium 1.5mg/kg/hr<br>* 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).<br>|
| Active Comparator: Control Group: Moderate Neuromuscular Blockade<br>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). | Drug: Rocuronium 0.3mg/kg/hr<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in levels of Intra-Abdominal Pressure (IAP) when performing robotic prostatectomy in participants under a moderate vs deep Neuromuscular Blockade technique |  | 1 year | 
| 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). | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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18-408, prostate cancer, robotic surgery, muscle relaxants, neuromuscular blockade, Memorial Sloan Kettering Cancer Center