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

Phase 2Active Not RecruitingNCT03808077

Memorial Sloan Kettering Cancer Center139 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

139

Conditions

Prostate Cancer

Interventions

Rocuronium 0.3mg/kg/hrDRUG

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).

Rocuronium 1.5mg/kg/hrDRUG

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).

Eligibility

Sex: MALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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