Trial Outcomes & Findings for Neuromuscular Blockade on Shoulder Pain of Elderly (NCT NCT03210376)
NCT ID: NCT03210376
Last Updated: 2020-11-25
Results Overview
Visual Analog Scale (VAS) pain score (0-10) for shoulder pain recorded, where 0 means no pain and 10 means the worst pain ever experienced . Percentage of participants who experienced should pain.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
30 days
Results posted on
2020-11-25
Participant Flow
Patients were identified when scheduled for Robotic Prostatectomy. Eligible subjects were approached before scheduled surgery to obtain Informed Consent. Patients were recruited from November, 2017 through July, 2018.
Participant milestones
| Measure |
Deep Neuromuscular Blockade (NMB) + Sugammadex
The patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the DNMB group, the rate will be adjusted and boluses given to maintain 1-2 post tetanic responses during the pneumoperitoneum. NMB will be reversed with Sugammadex 4 mg/Kg, intravenously as a single bolus injection, at the end of the surgery.
|
Moderate Neuromuscular Blockade (NMB) + Neostigmine
The patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the MNMB group, the Rocuronium infusion rate will be adjusted to maintain 1-2 TOF responses and will be reversed with Neostigmine 70 mcg/Kg up to a total of 5 mg, intravenously slowly over a period of at least 1 minute, at the end of surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neuromuscular Blockade on Shoulder Pain of Elderly
Baseline characteristics by cohort
| Measure |
Deep Neuromuscular Blockade (NMB) + Sugammadex
n=50 Participants
The patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the DNMB group, the rate will be adjusted and boluses given to maintain 1-2 post tetanic responses during the pneumoperitoneum. NMB will be reversed with Sugammadex 4 mg/Kg, intravenously as a single bolus injection, at the end of the surgery.
|
Moderate Neuromuscular Blockade (NMB) + Neostigmine
n=50 Participants
The patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the MNMB group, the Rocuronium infusion rate will be adjusted to maintain 1-2 TOF responses and will be reversed with Neostigmine 70 mcg/Kg up to a total of 5 mg, intravenously slowly over a period of at least 1 minute, at the end of surgery.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
44 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
|
Age, Continuous
|
69.12 years
STANDARD_DEVIATION 3.6289 • n=99 Participants
|
69.26 years
STANDARD_DEVIATION 3.6073 • n=107 Participants
|
69.19 years
STANDARD_DEVIATION 3.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=99 Participants
|
50 participants
n=107 Participants
|
100 participants
n=206 Participants
|
|
Body mass index (BMI)
|
29.044 kg/m^2
STANDARD_DEVIATION 4.8 • n=99 Participants
|
28.662 kg/m^2
STANDARD_DEVIATION 3.9567 • n=107 Participants
|
28.85 kg/m^2
STANDARD_DEVIATION 4.38 • n=206 Participants
|
|
Adjuvant or Immunotherapy
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 30 daysVisual Analog Scale (VAS) pain score (0-10) for shoulder pain recorded, where 0 means no pain and 10 means the worst pain ever experienced . Percentage of participants who experienced should pain.
Outcome measures
| Measure |
Deep Neuromuscular Blockade (NMB) + Sugammadex
n=50 Participants
The patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the DNMB group, the rate will be adjusted and boluses given to maintain 1-2 post tetanic responses during the pneumoperitoneum. NMB will be reversed with Sugammadex 4 mg/Kg, intravenously as a single bolus injection, at the end of the surgery.
|
Moderate Neuromuscular Blockade (NMB) + Neostigmine
n=50 Participants
The patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the MNMB group, the Rocuronium infusion rate will be adjusted to maintain 1-2 TOF responses and will be reversed with Neostigmine 70 mcg/Kg up to a total of 5 mg, intravenously slowly over a period of at least 1 minute, at the end of surgery.
|
|---|---|---|
|
Percentage of Patients Who Reported Shoulder Pain
|
12 percentage of participants
|
10 percentage of participants
|
SECONDARY outcome
Timeframe: Day 0 - IntraOperative-From beginning of pneumoperitoneum to desufflation (an average of 166 minutes)Intra-abdominal insufflation time and pressure directed by the surgeon and recorded continuously by the clinical coordinator until the time of desufflation.
Outcome measures
| Measure |
Deep Neuromuscular Blockade (NMB) + Sugammadex
n=50 Participants
The patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the DNMB group, the rate will be adjusted and boluses given to maintain 1-2 post tetanic responses during the pneumoperitoneum. NMB will be reversed with Sugammadex 4 mg/Kg, intravenously as a single bolus injection, at the end of the surgery.
|
Moderate Neuromuscular Blockade (NMB) + Neostigmine
n=50 Participants
The patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the MNMB group, the Rocuronium infusion rate will be adjusted to maintain 1-2 TOF responses and will be reversed with Neostigmine 70 mcg/Kg up to a total of 5 mg, intravenously slowly over a period of at least 1 minute, at the end of surgery.
|
|---|---|---|
|
Cumulative Intraoperative Insufflation Pressure
|
1995 mmHg
Interval 1104.0 to 3550.0
|
1581 mmHg
Interval 870.0 to 3555.0
|
SECONDARY outcome
Timeframe: Day 0 - Arrival time at PACU, an average of 3 minutesThe patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the DNMB group, the rate will be adjusted and boluses given to maintain 1-2 post tetanic responses during the pneumoperitoneum. NMB will be reversed with Sugammadex 4 mg/Kg, intravenously as a single bolus injection, at the end of the surgery. Percentage of measured contraction strength of the fourth stimulus compared to the first stimulus.
Outcome measures
| Measure |
Deep Neuromuscular Blockade (NMB) + Sugammadex
n=50 Participants
The patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the DNMB group, the rate will be adjusted and boluses given to maintain 1-2 post tetanic responses during the pneumoperitoneum. NMB will be reversed with Sugammadex 4 mg/Kg, intravenously as a single bolus injection, at the end of the surgery.
|
Moderate Neuromuscular Blockade (NMB) + Neostigmine
n=50 Participants
The patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the MNMB group, the Rocuronium infusion rate will be adjusted to maintain 1-2 TOF responses and will be reversed with Neostigmine 70 mcg/Kg up to a total of 5 mg, intravenously slowly over a period of at least 1 minute, at the end of surgery.
|
|---|---|---|
|
Percentage of Muscle Response Using Train-of-Four (TOF) in Post-Anesthesia Care Unit (PACU) to Measure Residual Muscle Relaxation
|
110 Percentage of measured contraction
Interval 70.0 to 174.0
|
100 Percentage of measured contraction
Interval 50.0 to 155.0
|
SECONDARY outcome
Timeframe: Assessed at 15, 45, 90 minutes during PACU stay.Determined by the Dansk Selskab for Anæstesiologi og Intensiv Medicin(DASAIM)discharge criteria.Pts considered ready to discharge when the sum of all categories is\<4 and no single category has a score of \>1.Sedation.0:Patient is fully awake.1: Patient is asleep,aroused by verbal stimulation.2:Patient is asleep, aroused by physical stimulation.3:Patient is asleep,cannot be aroused.Respiratory Rate.0:Respiratory rate\>10. 1: Snoring,10\< RR\<30. 2:R\<10 or RR\>30/min.3:Periods of apnea or obstructive patterns.Oxygen Saturation.0:SpO2 ≥ 94%.1:90%≤SpO2\<94%. 2:85%≤ SpO2 \< 90%.3:SpO2 \< 85%. Systolic Blood Pressure. 0:SBP ≥ 100mmHg.1:90mmHg≤SBP\< 100mmHg.2:80mmHg≤SBP\< 90mmHg or SBP\>220mmHg.3:SBP\<80mmHg.Heart Rate.0:50\<HR≤100.1:100\<HR≤120.2:40\<HR≤ 50 or 120\<HR≤130.3:HR\<40 or HR\>130.Pain at rest.0:No pain 1:Light pain.2:Moderate pain.3:Severe pain.Nausea.0:No nausea or vomiting.1:Light nausea or vomiting without previous nausea. 2:Moderate nausea and/or vomiting.3:Severe nausea and/or vomiting.
Outcome measures
| Measure |
Deep Neuromuscular Blockade (NMB) + Sugammadex
n=50 Participants
The patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the DNMB group, the rate will be adjusted and boluses given to maintain 1-2 post tetanic responses during the pneumoperitoneum. NMB will be reversed with Sugammadex 4 mg/Kg, intravenously as a single bolus injection, at the end of the surgery.
|
Moderate Neuromuscular Blockade (NMB) + Neostigmine
n=50 Participants
The patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the MNMB group, the Rocuronium infusion rate will be adjusted to maintain 1-2 TOF responses and will be reversed with Neostigmine 70 mcg/Kg up to a total of 5 mg, intravenously slowly over a period of at least 1 minute, at the end of surgery.
|
|---|---|---|
|
Readiness to Discharge From the Post-Anesthesia Care Unit (PACU)
DASAIM at 15 min
|
2.92 Score on a scale
Standard Deviation 1.6393
|
3.16 Score on a scale
Standard Deviation 1.6946
|
|
Readiness to Discharge From the Post-Anesthesia Care Unit (PACU)
DASAIM at 45 min
|
2.82 Score on a scale
Standard Deviation 1.6744
|
2.86 Score on a scale
Standard Deviation 1.6904
|
|
Readiness to Discharge From the Post-Anesthesia Care Unit (PACU)
DASAIM at 90 min
|
2.12 Score on a scale
Standard Deviation 1.599
|
1.8 Score on a scale
Standard Deviation 1.4286
|
SECONDARY outcome
Timeframe: Day 0 - PACU stay, an average of 120 minutesDegree of Post-Operative Nausea determined per Visual Analog Scale per nurse in Post-Anesthesia Care Unit (PACU).
Outcome measures
| Measure |
Deep Neuromuscular Blockade (NMB) + Sugammadex
n=50 Participants
The patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the DNMB group, the rate will be adjusted and boluses given to maintain 1-2 post tetanic responses during the pneumoperitoneum. NMB will be reversed with Sugammadex 4 mg/Kg, intravenously as a single bolus injection, at the end of the surgery.
|
Moderate Neuromuscular Blockade (NMB) + Neostigmine
n=50 Participants
The patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the MNMB group, the Rocuronium infusion rate will be adjusted to maintain 1-2 TOF responses and will be reversed with Neostigmine 70 mcg/Kg up to a total of 5 mg, intravenously slowly over a period of at least 1 minute, at the end of surgery.
|
|---|---|---|
|
Percentage of Participants With Nausea and/or Vomiting in PACU
Nausea
|
7 percentage of participants
|
6 percentage of participants
|
|
Percentage of Participants With Nausea and/or Vomiting in PACU
Vomiting
|
1 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 0 - IntraOperative, from incision time to closing time(average 190 minutes)Outcome measures
| Measure |
Deep Neuromuscular Blockade (NMB) + Sugammadex
n=50 Participants
The patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the DNMB group, the rate will be adjusted and boluses given to maintain 1-2 post tetanic responses during the pneumoperitoneum. NMB will be reversed with Sugammadex 4 mg/Kg, intravenously as a single bolus injection, at the end of the surgery.
|
Moderate Neuromuscular Blockade (NMB) + Neostigmine
n=50 Participants
The patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the MNMB group, the Rocuronium infusion rate will be adjusted to maintain 1-2 TOF responses and will be reversed with Neostigmine 70 mcg/Kg up to a total of 5 mg, intravenously slowly over a period of at least 1 minute, at the end of surgery.
|
|---|---|---|
|
Surgical Exposure Grading
Optimal
|
25 Participants
|
33 Participants
|
|
Surgical Exposure Grading
Good
|
19 Participants
|
8 Participants
|
|
Surgical Exposure Grading
Acceptable
|
5 Participants
|
8 Participants
|
|
Surgical Exposure Grading
Poor
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: length of hospital stay(average of 3 days)Outcome measures
| Measure |
Deep Neuromuscular Blockade (NMB) + Sugammadex
n=50 Participants
The patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the DNMB group, the rate will be adjusted and boluses given to maintain 1-2 post tetanic responses during the pneumoperitoneum. NMB will be reversed with Sugammadex 4 mg/Kg, intravenously as a single bolus injection, at the end of the surgery.
|
Moderate Neuromuscular Blockade (NMB) + Neostigmine
n=50 Participants
The patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the MNMB group, the Rocuronium infusion rate will be adjusted to maintain 1-2 TOF responses and will be reversed with Neostigmine 70 mcg/Kg up to a total of 5 mg, intravenously slowly over a period of at least 1 minute, at the end of surgery.
|
|---|---|---|
|
Length of Hospital Stay
|
2.2323 days
Standard Deviation 2.0859
|
1.8623 days
Standard Deviation 1.0545
|
Adverse Events
Deep Neuromuscular Blockade (NMB) + Sugammadex
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
Moderate Neuromuscular Blockade (NMB) + Neostigmine
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Deep Neuromuscular Blockade (NMB) + Sugammadex
n=50 participants at risk
The patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the DNMB group, the rate will be adjusted and boluses given to maintain 1-2 post tetanic responses during the pneumoperitoneum. NMB will be reversed with Sugammadex 4 mg/Kg, intravenously as a single bolus injection, at the end of the surgery.
|
Moderate Neuromuscular Blockade (NMB) + Neostigmine
n=50 participants at risk
The patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the MNMB group, the Rocuronium infusion rate will be adjusted to maintain 1-2 TOF responses and will be reversed with Neostigmine 70 mcg/Kg up to a total of 5 mg, intravenously slowly over a period of at least 1 minute, at the end of surgery.
|
|---|---|---|
|
Cardiac disorders
Chest Pain
|
2.0%
1/50 • 1 month
|
0.00%
0/50 • 1 month
|
|
Musculoskeletal and connective tissue disorders
Incarcerated Inguinal Hernia
|
2.0%
1/50 • 1 month
|
0.00%
0/50 • 1 month
|
|
Gastrointestinal disorders
Partial Small Bowel Obstruction
|
2.0%
1/50 • 1 month
|
0.00%
0/50 • 1 month
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/50 • 1 month
|
2.0%
1/50 • 1 month
|
|
Gastrointestinal disorders
Anastomosis Leak
|
0.00%
0/50 • 1 month
|
2.0%
1/50 • 1 month
|
Other adverse events
| Measure |
Deep Neuromuscular Blockade (NMB) + Sugammadex
n=50 participants at risk
The patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the DNMB group, the rate will be adjusted and boluses given to maintain 1-2 post tetanic responses during the pneumoperitoneum. NMB will be reversed with Sugammadex 4 mg/Kg, intravenously as a single bolus injection, at the end of the surgery.
|
Moderate Neuromuscular Blockade (NMB) + Neostigmine
n=50 participants at risk
The patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the MNMB group, the Rocuronium infusion rate will be adjusted to maintain 1-2 TOF responses and will be reversed with Neostigmine 70 mcg/Kg up to a total of 5 mg, intravenously slowly over a period of at least 1 minute, at the end of surgery.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
2.0%
1/50 • 1 month
|
0.00%
0/50 • 1 month
|
|
Cardiac disorders
Chest Pain
|
2.0%
1/50 • 1 month
|
0.00%
0/50 • 1 month
|
|
Immune system disorders
Fever
|
2.0%
1/50 • 1 month
|
0.00%
0/50 • 1 month
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
8.0%
4/50 • 1 month
|
16.0%
8/50 • 1 month
|
|
Gastrointestinal disorders
Postoperative Ileus
|
8.0%
4/50 • 1 month
|
2.0%
1/50 • 1 month
|
|
Renal and urinary disorders
Urinary Tract Infection
|
8.0%
4/50 • 1 month
|
6.0%
3/50 • 1 month
|
|
Vascular disorders
Low O2 Sat
|
0.00%
0/50 • 1 month
|
2.0%
1/50 • 1 month
|
|
Skin and subcutaneous tissue disorders
Infected Incision
|
0.00%
0/50 • 1 month
|
2.0%
1/50 • 1 month
|
|
Vascular disorders
Uncontrolled Hypertension
|
0.00%
0/50 • 1 month
|
2.0%
1/50 • 1 month
|
|
Nervous system disorders
Restlessness Legs
|
0.00%
0/50 • 1 month
|
2.0%
1/50 • 1 month
|
Additional Information
Dr. Wendell H. Williams III / Anesthesiology & Perioperative Medicine
UT MD Anderson Cancer Center
Phone: 713-563-0034
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place