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

NCT03808077 | Active Not Recruiting Phase 2 Results FDA Drug

• 1 other identifier: 18-408
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

prostate cancer; robotic surgery; muscle relaxants; neuromuscular blockade; 18-408; Memorial Sloan Kettering Cancer Center

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  6 hours post operation

Study Arms (2)

Interventional Group: Deep Neuromuscular Blockade

EXPERIMENTAL

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

Control Group: Moderate Neuromuscular Blockade

ACTIVE COMPARATOR

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

Interventions

Rocuronium 0.3mg/kg/hr DRUG

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).

Control Group: Moderate Neuromuscular Blockade

Rocuronium 1.5mg/kg/hr DRUG

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).

Interventional Group: Deep Neuromuscular Blockade

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

• Tanaka A, Cai T, Platten M, Tollinche LE, DeJoy SJ. Anesthetic Management and Neuromonitoring in a Patient with Very Long-Chain Acyl-Coenzyme A Dehydrogenase Deficiency Undergoing Scoliosis Surgery: A Case Report and Review of Literature. Case Rep Anesthesiol. 2024 Jan 8;2024:1050279. doi: 10.1155/2024/1050279. eCollection 2024.

  PMID: 38229914 DERIVED

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms; Muscle Hypotonia

Interventions

Rocuronium

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Elizabeth Rieth, MD
• Organization: Memorial Sloan Kettering Cancer Center

riethe@mskcc.org

212-639-5737

Study Officials

• Elizabeth Rieth, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 17, 2019
• Study Start: January 14, 2019
• Primary Completion: October 11, 2024
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 9, 2026
• Results First Posted: June 19, 2025

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)