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Muscle Relaxants During Robotic Surgery for Prostate Cancer

Phase 2

Waitlist Available

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

Must not have

Age younger than 18

Neuromuscular disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I have a neuromuscular disease.

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I am currently taking suboxone.

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I am currently taking succinylcholine.

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My kidneys are not working well (very low filtration rate).

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My BMI is over 35.

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I am currently taking or have taken Toremifene.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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).

0 / 9Eligibility criteria met