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

Phase 2

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: Drug: Rocuronium 0.3mg/kg/hr; Drug: Rocuronium 1.5mg/kg/hr

• Registration Number: NCT03808077
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2019-01-14
• Study First Submitted: 2019-01-15
• Study First Submitted QC: 2019-01-16
• Study First Posted: 2019-01-17
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-15
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 139

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group: Moderate Neuromuscular Blockade	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).
Interventional Group: Deep Neuromuscular Blockade	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).

Primary Outcome Measures

Name	Time	Method
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).	1 year	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).
Difference in levels of Intra-Abdominal Pressure (IAP) when performing robotic prostatectomy in participants under a moderate vs deep Neuromuscular Blockade technique	1 year

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States