This phase II trial studies how well prostate surgery with deep neuromuscular blockade works compared to moderate neuromuscular blockade in reducing post-surgery pain in patients with prostate cancer who are undergoing minimally invasive robotic prostatectomy. A neuromuscular blockade is a type of muscle relaxant that works together with anesthesia to keep the body still during surgery and may affect the levels of post-surgery pain. Deep neuromuscular blockade (a higher dose of neuromuscular blocker) may decrease the need for increased intra-abdominal pressure during surgery and reduce post-surgery pain as compared to using moderate neuromuscular blockade in patients with prostate cancer undergoing minimally invasive robotic prostatectomy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03808077.
PRIMARY OBJECTIVES:
I. Investigate if different levels of intra-abdominal pressure (IAP) will be utilized when performing robotic prostatectomy in patients under a moderate neuromuscular blockade (NMB) technique versus (vs.) patients under a deep NMB technique.
II. Investigate if there is a difference in patient-reported postoperative pain in patients under moderate NMB vs. patients under deep NMB during robotic prostatectomy.
SECONDARY OBJECTIVES:
I. Investigate if there is a difference in surgeon assessment of surgical exposure when performing surgery under deep vs. moderate NMB.
II. Investigate and compare the total dose of analgesics during the procedure, the total dose of analgesics during the procedure, the total dose of analgesics postoperatively, postoperative shoulder pain, total intraoperative blood loss, operating time, postoperative nausea, time to the first postoperative antiemetic, total dose of antiemetics postoperatively, and postoperative RASS scores (Richmond Agitation Sedation Scale) between deep and moderate NMB.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (MODERATE BLOCKADE): Patients undergo prostatectomy and receive moderate neuromuscular blockade. At the first sign of recovery from neuromuscular blockade, patients receive a standard dose of rocuronium infusion titrated to moderate paralysis.
GROUP II (DEEP BLOCKADE): Patients undergo prostatectomy and receive deep neuromuscular blockade. At the first sign of recovery from neuromuscular blockade, patients receive a high dose of rocuronium infusion titrated to deep paralysis.
After completion of study treatment, patients are followed up periodically.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorElizabeth Rieth
