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Muscle Relaxants During Robotic Surgery for Prostate Cancer

Phase 2

Recruiting

Led By Luis Tollinche, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

American Society of Anesthesiologists Physical Status 1, 2, 3

Adult patients under the age of 80

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial will compare deep vs moderate neuromuscular blockade in men undergoing robotic prostate surgery to see if there is a difference in post-surgery pain.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Possible side effects from Rocuronium include allergic reactions, changes in blood pressure or heart rate, breathing difficulties, muscle weakness after surgery which may affect recovery time.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am under 80 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Difference in levels of Intra-Abdominal Pressure (IAP) when performing robotic prostatectomy in participants under a moderate vs deep Neuromuscular Blockade technique

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).

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Interventional Group: Deep Neuromuscular BlockadeExperimental Treatment1 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 BlockadeActive Control1 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).

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,796 Total Patients Enrolled

132 Trials studying Prostate Cancer

51,944 Patients Enrolled for Prostate Cancer

Luis Tollinche, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Cindy Yeoh, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Prostate Cancer Research Study Groups: Interventional Group: Deep Neuromuscular Blockade, Control Group: Moderate Neuromuscular Blockade

Rocuronium 1.5mg/kg/hr 2023 Treatment Timeline for Medical Study. Trial Name: NCT03808077 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what situations is Rocuronium 1.5mg/kg/hr most prescribed?

"intubation (procedure), muscular fasciculation, and curarization therapy can all be effectively treated by using Rocuronium 1.5mg/kg/hr."

Answered by AI

Are there any previous instances of Rocuronium 1.5mg/kg/hr being used in research?

"Currently, there are 16 ongoing studies evaluating the effects of Rocuronium 1.5mg/kg/hr with 3 Phase 3 trials underway. Of the 29 total clinical trial sites for Rocuronium 1.5mg/kg/hr, several are based in Montreal, Quebec."

Answered by AI

What makes this particular trial innovative or unique?

"Data shows that there are 16 different ongoing clinical trials for Rocuronium 1.5mg/kg/hr in 11 cities and 10 countries. The first ever trial of its kind was completed in 2009 by Medtronic - MITG. That particular study had 80 participants and finished its N/A drug approval stage. In the last 12 years, 135 similar trials have been conducted."

Answered by AI

Are there any specific inclusion criteria for this research?

"This particular clinical trial is looking for 130 patients that have prostate cancer and are between 18-80 years old. Other requirements include being an adult under 80 years old who will be undergoing surgery at Josie Robertson Surgical Center."

Answered by AI

Could you please highlight any potential dangers of Rocuronium 1.5mg/kg/hr for patients?

"Rocuronium 1.5mg/kg/hr is estimated to be a 2 in terms of safety by our team because it is in Phase 2 of clinical trials. This lack of efficacy data means that, while some safety data exists, there is none to support its use as an effective medication."

Answered by AI

How many people are being signed up for this experiment?

"Yes, according to the information displayed on clinicaltrials.gov, this study is still recruiting patients. The trial was originally posted on 1/14/2019 and was last updated on 7/12/2022. Currently, the research team is looking for 130 individuals who are willing to participate at one of two locations."

Answered by AI

Does this test case allow for elderly patients?

"The age limit for this particular clinical trial is 18 to 80 years old. There are a total of 85 trials for patients that meet the under-18 criteria and 1,371 trials for people who exceed 65 years of age."

Answered by AI

Are patients currently being accepted for this trial period?

"Yes, as the clinicaltrials.gov website reports, this trial is open and actively recruiting participants. The study was posted on January 14th, 2019 and was last edited on July 12th, 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "The Effect of Deep Versus Moderate Muscle Relaxants in Men During and After Robotic Surgery for Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03808077.

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