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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Rocuronium 0.3mg/kg/hr; Drug: Rocuronium 1.5mg/kg/hr

Study type: Interventional

Funder types: Other

Identifiers

NCT03808077

18-408

Details and patient eligibility

About

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.

Enrollment: 139 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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139 participants in 2 patient groups

Interventional Group: Deep Neuromuscular Blockade

Experimental group

Description:

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).

Treatment:

Drug: Rocuronium 1.5mg/kg/hr

Control Group: Moderate Neuromuscular Blockade

Active Comparator group

Description:

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).

Treatment:

Drug: Rocuronium 0.3mg/kg/hr