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

Prostate Cancer Clinical Trial

Official title:

A Randomized Controlled Trial to Compare the Effectiveness of Deep vs. Moderate Neuromuscular Blockade in Reducing Postoperative Pain and Intra-Abdominal Insufflation Pressure During Minimally Invasive Robotic Prostatectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03808077
• Other study ID #: 18-408
• Status: Recruiting
• Phase: Phase 2
• Start date: January 14, 2019
• Est. completion date: January 2025

Study information

• Verified date: February 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Elizabeth Rieth, MD
• Phone: 212-639-5737
• Email: riethe[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Rocuronium 0.3mg/kg/hr
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).
• 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 0.025mg/kg/min or 1.5mg/kg/hr).

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in levels of Intra-Abdominal Pressure (IAP) when performing robotic prostatectomy in participants under a moderate vs deep Neuromuscular Blockade technique		1 year
Primary	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).	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). The numeric pain scale (NPS) is a subjective measure which can be used in recovery rooms to assist in the assessment of pain. Individuals rate their pain on an eleven-point scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).	1 year

External Links

•   Memorial Sloan Kettering Cancer Center