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Rocuronium Dose Comparison for Prostate Cancer Surgery

Memorial Sloan Kettering Cancer Center, New York, NY
Rocuronium 1.5mg/kg/hr +1 morePhase 2RecruitingLed by Luis Tollinche, MDResearch Sponsored by Memorial Sloan Kettering Cancer Center

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.

Eligible Conditions
  • Prostate Cancer

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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The study is only for men who need to have their prostate removed with robotic surgery.

Timeline

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).

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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).

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,911 Previous Clinical Trials
588,812 Total Patients Enrolled
130 Trials studying Prostate Cancer
65,737 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
~2 spots leftby Jan 2024