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NCT Number: NCT03808077

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Muscle Hypotonia Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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).

Primary outcomes

  1. Mean Difference in Intra-Abdominal Pressure (IAP) When Performing Robotic Prostatectomy in Participants Under a Moderate vs Deep Neuromuscular Blockade Technique

    Time frame: 6 hours post operation

    Measured by continuous Intra-abdominal Pressure monitor in mmHg.

  2. 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).

    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). 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).

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2027
First posted
Jan 17, 2019
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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