Clinical trial · Interventional
The Effect of Deep Versus Moderate Muscle Relaxants in Men During and After Robotic Surgery for Prostate Cancer
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
NCT03808077CI-TRIAL-00104979active not recruitingPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rocuronium 0.3mg/kg/hr | Drug | — | UNRESOLVED |
| Rocuronium 1.5mg/kg/hr | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Interventional Group: Deep Neuromuscular Blockade
- description
- 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).
- interventionNames
- Drug: Rocuronium 1.5mg/kg/hr
- type
- ACTIVE_COMPARATOR
- label
- Control Group: Moderate Neuromuscular Blockade
- description
- 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).
- interventionNames
- Drug: Rocuronium 0.3mg/kg/hr
Primary outcomes (2)
- measure
- Mean Difference in Intra-Abdominal Pressure (IAP) When Performing Robotic Prostatectomy in Participants Under a Moderate vs Deep Neuromuscular Blockade Technique
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDTanaka A, Cai T, Platten M, Tollinche LE, DeJoy SJ. Anesthetic Management and Neuromonitoring in a Patient with Very Long-Chain Acyl-Coenzyme A Dehydrogenase Deficiency Undergoing Scoliosis Surgery: A Case Report and Review of Literature. Case Rep Anesthesiol. 2024 Jan 8;2024:1050279. doi: 10.1155/2024/1050279. eCollection 2024. PMID 38229914