Muscle Relaxants During Robotic Surgery for Prostate Cancer

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether varying levels of muscle relaxation during robotic prostate surgery affect abdominal pressure and post-surgery pain. Participants will receive one of two doses of the muscle relaxant rocuronium: either a deep or moderate dose. The trial seeks men scheduled for robotic prostate surgery who do not have certain allergies or health issues, such as chronic pain or a high BMI (Body Mass Index over 35). The goal is to identify the best surgical management for reduced pain and improved outcomes. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to advancements in surgical care.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that rocuronium, the drug used in this trial, is well-studied for surgical use. Rocuronium, a muscle relaxant, aids doctors by relaxing muscles during surgery. It is known for its quick action and moderate duration of effects.

Studies have demonstrated that deep muscle relaxation with rocuronium does not significantly affect breathing during surgery, suggesting it creates favorable surgical conditions without major side effects.

Although this trial is in the early phase, rocuronium's established use in surgeries provides some assurance about its safety. However, like any treatment, risks exist, and discussing any concerns with the study team is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they explore different levels of muscle relaxation during robotic prostate cancer surgery, which might improve surgical precision and patient safety. Unlike the standard of care, which typically involves moderate neuromuscular blockade, this trial examines both moderate and deep neuromuscular blockade using rocuronium at varying doses. The deep neuromuscular blockade could offer more stable surgical conditions by achieving deeper muscle relaxation, potentially leading to fewer complications and a smoother recovery. By understanding the impact of these different blockade levels, this trial aims to optimize surgical outcomes and enhance the overall treatment experience for patients undergoing robotic prostate cancer surgery.

What evidence suggests that this trial's treatments could be effective for prostate cancer surgery?

This trial will compare the effects of different doses of rocuronium during robotic prostate surgery. Research has shown that using rocuronium at a specific dose can improve surgical conditions by deeply relaxing muscles, making it easier for surgeons to perform the procedure and potentially leading to better patient outcomes. Participants in the Deep Neuromuscular Blockade group will receive a higher dose of rocuronium, while those in the Moderate Neuromuscular Blockade group will receive a lower dose. Studies indicate that deep muscle relaxation does not significantly affect breathing during surgery. However, its impact on postoperative pain remains unclear. Overall, using rocuronium in this manner appears promising for enhancing the surgical process. ^{1 2 4 5 6}

Who Is on the Research Team?

Elizabeth Rieth, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03808077?tab=results

The Effect of Deep Versus Moderate Muscle Relaxants in ... Rocuronium 1.5mg/kg/hr: The Deep NMB group (Intervention) will have rocuronium infusion titrated to deep paralysis defined as PTC of 1-2 (infusion start rate ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03808077

The Effect of Deep Versus Moderate Muscle Relaxants in ... 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

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8584864/

Effect of Neuromuscular Blockade on Intraoperative ... In conclusion, deep NMB had no significant effect on the intraoperative respiratory mechanics but resulted in optimal endoscopic surgical conditions during RARP ...

4. ctv.veeva.com ctv.veeva.com/study/the-effect-of-deep-versus-moderate-muscle-relaxants-in-men-during-and-after-robotic-surgery-for-pros

The Effect of Deep Versus Moderate Muscle Relaxants in Men ... The purpose of this study is to determine if there is a difference in intra-abdominal pressure which surgeons use during surgery and ...

5. clinicaltrial.be clinicaltrial.be/en/details/65637?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

The Effect of Deep Versus Moderate Muscle Relaxants in ... The purpose of this study is to determine if there is a difference in intra-abdominal pressure which surgeons use during surgery and ...

6. withpower.com withpower.com/trial/phase-3-prostatic-neoplasms-2019-db763

Muscle Relaxants During Robotic Surgery for Prostate ... Rocuronium is a muscle relaxant used during surgery that has a rapid onset and intermediate duration, making it suitable for quick and effective muscle ...