Muscle Relaxants During Robotic Surgery for Prostate Cancer

Recruiting at 1 trial location

Overseen By Marielle Palop Soeprono, CRNA

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Toremifene, Suboxone, Succinylcholine

Disqualifiers: Neuromuscular disease, Chronic pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

139 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are taking Toremifene, suboxone, or succinylcholine, you cannot participate.

What data supports the effectiveness of the drug Rocuronium for use during robotic surgery for prostate cancer?

Rocuronium is a muscle relaxant that works quickly and is effective in creating good conditions for intubation (inserting a tube into the windpipe) during surgery, as shown in studies with doses similar to those used in your trial. It has been found to be a useful alternative to other muscle relaxants for rapid procedures, which may support its use in robotic surgery for prostate cancer. ^{1 2 3 4 5}

Is rocuronium generally safe for use in humans?

Rocuronium is generally considered safe for use in humans, with studies showing it has a stable heart rate and no histamine release even at high doses. It has been used successfully in various surgeries, including emergency and cardiovascular procedures, without significant adverse effects. ^{2 3 6 7 8}

How does the drug rocuronium differ from other treatments for prostate cancer surgery?

Rocuronium is a muscle relaxant used during surgery that has a rapid onset and intermediate duration, making it suitable for quick and effective muscle relaxation during robotic prostate cancer surgery. This differs from other treatments as it specifically aids in providing optimal surgical conditions by relaxing muscles, which is crucial for the precision required in robotic procedures. ^{1 2 9 10 11}

What is the purpose of this trial?

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.

Research Team

Elizabeth Rieth, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for men under 80 years old undergoing elective robotic prostate surgery without neuromuscular diseases, severe renal impairment, or a history of certain abdominal surgeries. They must not have allergies to specific anesthetics and pain medications, and cannot be on drugs like suboxone or Toremifene.

Inclusion Criteria

I am having surgery at Josie Robertson Surgical Center.

My health is good to moderately impaired according to the ASA scale.

I am under 80 years old.

Exclusion Criteria

I am under 18 years old.

Inability to provide informed consent

I have a neuromuscular disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo robotic prostate surgery with either deep or moderate neuromuscular blockade

1 day

1 visit (in-person)

Follow-up

Participants are monitored for intra-abdominal pressure and postoperative pain for up to 1 year

1 year

Treatment Details

Interventions

• Rocuronium 0.3mg/kg/hr
• Rocuronium 1.5mg/kg/hr

Trial Overview The study compares the effects of two different doses of Rocuronium (a muscle relaxant) during robotic prostate cancer surgery: one group receives a deep level (1.5mg/kg/hr), while another gets a moderate level (0.3mg/kg/hr). The focus is on intra-abdominal pressure used by surgeons and post-surgery pain levels.

Participant Groups

Group I: Interventional Group: Deep Neuromuscular Blockade Experimental Treatment 1 Intervention

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).

Group II: Control Group: Moderate Neuromuscular Blockade Active Control 1 Intervention

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).

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Findings from Research

Rocuronium is a nondepolarizing neuromuscular blocking agent that acts quickly, making it ideal for situations requiring rapid intubation, and it does not produce active metabolites, enhancing its safety profile.

It has been successfully used in various high-risk surgical settings, including emergency surgeries and cesarean deliveries, due to its hemodynamic stability and predictable reversibility of effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Rocuronium]. Alvarez-Gómez, JA.[2018]

References

1. Thailand pubmed.ncbi.nlm.nih.gov

Intubating conditions after three different doses of rocuronium. [2018]

2. Germany pubmed.ncbi.nlm.nih.gov

[Intubation requirements after rocuronium and succinylcholine]. [2018]

3. England pubmed.ncbi.nlm.nih.gov

A comparison of the pharmacodynamics of rocuronium and vecuronium during halothane anaesthesia. [2019]

4. India pubmed.ncbi.nlm.nih.gov

Effect of muscle relaxants on heart rate, arterial pressure, intubation conditions and onset of neuromuscular block in patients undergoing valve surgery. [2009]

5. England pubmed.ncbi.nlm.nih.gov

Neuromuscular effects of rocuronium bromide (Org 9426) during fentanyl and halothane anaesthesia. [2019]

6. France pubmed.ncbi.nlm.nih.gov

Time-course of action of rocuronium 0.3 mg.kg-1 in children with and without endstage renal failure. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Safety aspects of non-depolarizing neuromuscular blocking agents with special reference to rocuronium bromide. [2018]

8. Spain pubmed.ncbi.nlm.nih.gov

[Rocuronium]. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Pharmacodynamics of rocuronium 0.3 mg kg(-1) in adult patients with and without renal failure. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Dose-response relationships for edrophonium and neostigmine antagonism of rocuronium bromide (ORG 9426)-induced neuromuscular blockade. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Rocuronium 0.3 or 0.9 mg/kg comparing onset time, duration of action, and intubating conditions in patients 80 years and older: A randomized study. [2022]