Trial Outcomes & Findings for The Effect of Deep Versus Moderate Muscle Relaxants in Men During and After Robotic Surgery for Prostate Cancer (NCT NCT03808077)
NCT ID: NCT03808077
Last Updated: 2026-03-09
Results Overview
Measured by continuous Intra-abdominal Pressure monitor in mmHg.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
139 participants
Primary outcome timeframe
6 hours post operation
Results posted on
2026-03-09
Participant Flow
Participant milestones
| Measure |
Interventional Group: Deep Neuromuscular Blockade
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).
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 0.006mg/kg/min or 0.35mg/kg/hr).
|
Control Group: Moderate Neuromuscular Blockade
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 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 0.003 mg/kg/min or 0.18mg/kg/hr).
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
67
|
|
Overall Study
COMPLETED
|
67
|
63
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
Interventional Group: Deep Neuromuscular Blockade
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).
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 0.006mg/kg/min or 0.35mg/kg/hr).
|
Control Group: Moderate Neuromuscular Blockade
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 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 0.003 mg/kg/min or 0.18mg/kg/hr).
|
|---|---|---|
|
Overall Study
Physician Decision
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Equipment Issues
|
2
|
1
|
Baseline Characteristics
The Effect of Deep Versus Moderate Muscle Relaxants in Men During and After Robotic Surgery for Prostate Cancer
Baseline characteristics by cohort
| Measure |
Interventional Group: Deep Neuromuscular Blockade
n=72 Participants
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).
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 0.006mg/kg/min or 0.35mg/kg/hr).
|
Control Group: Moderate Neuromuscular Blockade
n=67 Participants
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 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 0.003 mg/kg/min or 0.18mg/kg/hr).
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
n=68 Participants
|
63 years
n=69 Participants
|
63 years
n=137 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=68 Participants
|
67 Participants
n=69 Participants
|
139 Participants
n=137 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=68 Participants
|
5 Participants
n=69 Participants
|
8 Participants
n=137 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
68 Participants
n=68 Participants
|
59 Participants
n=69 Participants
|
127 Participants
n=137 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=68 Participants
|
3 Participants
n=69 Participants
|
4 Participants
n=137 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=68 Participants
|
3 Participants
n=69 Participants
|
4 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=68 Participants
|
9 Participants
n=69 Participants
|
20 Participants
n=137 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=68 Participants
|
52 Participants
n=69 Participants
|
112 Participants
n=137 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
|
3 Participants
n=69 Participants
|
3 Participants
n=137 Participants
|
|
Region of Enrollment
United States
|
72 Participants
n=68 Participants
|
67 Participants
n=69 Participants
|
139 Participants
n=137 Participants
|
PRIMARY outcome
Timeframe: 6 hours post operationMeasured by continuous Intra-abdominal Pressure monitor in mmHg.
Outcome measures
| Measure |
Interventional Group: Deep Neuromuscular Blockade
n=72 Participants
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).
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 0.006mg/kg/min or 0.35mg/kg/hr).
|
Control Group: Moderate Neuromuscular Blockade
n=67 Participants
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 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 0.003 mg/kg/min or 0.18mg/kg/hr).
|
|---|---|---|
|
Mean Difference in Intra-Abdominal Pressure (IAP) When Performing Robotic Prostatectomy in Participants Under a Moderate vs Deep Neuromuscular Blockade Technique
|
10.50 mmHg
Interval 8.93 to 12.71
|
11.41 mmHg
Interval 9.88 to 12.9
|
PRIMARY outcome
Timeframe: 6 hours post operationDifference 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).
Outcome measures
| Measure |
Interventional Group: Deep Neuromuscular Blockade
n=72 Participants
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).
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 0.006mg/kg/min or 0.35mg/kg/hr).
|
Control Group: Moderate Neuromuscular Blockade
n=67 Participants
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 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 0.003 mg/kg/min or 0.18mg/kg/hr).
|
|---|---|---|
|
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).
|
3.25 score on a scale
Interval 1.9 to 4.14
|
3.41 score on a scale
Interval 2.14 to 4.94
|
Adverse Events
Interventional Group: Deep Neuromuscular Blockade
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group: Moderate Neuromuscular Blockade
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Interventional Group: Deep Neuromuscular Blockade
n=72 participants at risk
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).
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 0.006mg/kg/min or 0.35mg/kg/hr).
|
Control Group: Moderate Neuromuscular Blockade
n=67 participants at risk
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 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 0.003 mg/kg/min or 0.18mg/kg/hr).
|
|---|---|---|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.4%
1/72 • 1 year
|
0.00%
0/67 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Elizabeth Rieth, MD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-5737
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place