Active — Not RecruitingPhase 2

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

United States139 participantsStarted 2019-01-14

Plain-language summary

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.

Who can participate

Age range18 Years – 80 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients under the age of 80 * American Society of Anesthesiologists Physical Status 1, 2, 3. * Elective Robotic Prostatectomy * Patient undergoing surgery at Josie Robertson Surgical Center Exclusion Criteria: * Age younger than 18 * Inability to provide informed consent * Allergy to rocuronium, sugammadex, midazolam, propofol, fentanyl, lidocaine, mannitol (IV Acetaeminophen), IV Acetaminophen, Ketorolac, Morphine, Hydromorphone, Dexamethasone, Zofran, Benadryl, Compazine * Neuromuscular disease * Any patient with previous abdominal surgery less than or equal to 20 years prior to scheduled surgery date * Patients with BMI\>35 * Severe renal impairment (Creatinine clearance \< 30 ml/min) * Patient receiving Toremifene or any history of receiving Toremifene * Chronic pain patients * Patients receiving suboxone * Patients receiving succinylcholine

What they're measuring

Mean Difference in Intra-Abdominal Pressure (IAP) When Performing Robotic Prostatectomy in Participants Under a Moderate vs Deep Neuromuscular Blockade Technique

Timeframe: 6 hours post operation

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).

Timeframe: 6 hours post operation

Trial details

NCT IDNCT03808077

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-11

Results submitted2025-04-25

View on ClinicalTrials.gov More Prostate Cancer trials

Who can participate

Age range18 Years – 80 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Mean Difference in Intra-Abdominal Pressure (IAP) When Performing Robotic Prostatectomy in Participants Under a Moderate vs Deep Neuromuscular Blockade Technique

Timeframe: 6 hours post operation

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).

Timeframe: 6 hours post operation