Trial Outcomes & Findings for Sugammadex To IMprove Bowel Function (NCT NCT04546672)
NCT ID: NCT04546672
Last Updated: 2024-07-29
Results Overview
Gastric emptying as assessed by the area under the paracetamol concentration-time curve by trapezoidal approximation (AUC)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
120 participants
Primary outcome timeframe
150 minutes after neuromuscular reversal
Results posted on
2024-07-29
Participant Flow
Participant milestones
| Measure |
Sugammadex
Sugammadex 2 mg/kg IV once at the end of surgery
Sugammadex: At the end of the surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Sugammadex will be dosed once at 2 mg/kg actual body weight through an intravenous line with brisk flow
|
Neostigmine
Neostigmine 0.07 mg/kg to a maximum of 5 mg (+Glycopyrrolate 0.2 mg per 1 mg of neostigmine administered) IV once at the end of surgery
Neostigmine: At the end of surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Neostigmine will be dosed once at 0.07 mg/kg actual body weight to a maximum of 5 mg through an intravenous line with brisk flow. Glycopyrrolate will be coadministered with Neostigmine at a dose of 0.2 mg of Glycopyrrolate per 1.0 mg of Neostigmine administered
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
60
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sugammadex To IMprove Bowel Function
Baseline characteristics by cohort
| Measure |
Sugammadex
n=60 Participants
Sugammadex 2 mg/kg IV once at the end of surgery
Sugammadex: At the end of the surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Sugammadex will be dosed once at 2 mg/kg actual body weight through an intravenous line with brisk flow
|
Neostigmine
n=60 Participants
Neostigmine 0.07 mg/kg to a maximum of 5 mg (+Glycopyrrolate 0.2 mg per 1 mg of neostigmine administered) IV once at the end of surgery
Neostigmine: At the end of surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Neostigmine will be dosed once at 0.07 mg/kg actual body weight to a maximum of 5 mg through an intravenous line with brisk flow. Glycopyrrolate will be coadministered with Neostigmine at a dose of 0.2 mg of Glycopyrrolate per 1.0 mg of Neostigmine administered
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 13.2 • n=99 Participants
|
55.9 years
STANDARD_DEVIATION 14.0 • n=107 Participants
|
56.4 years
STANDARD_DEVIATION 13.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
59 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
117 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
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 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
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
57 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
112 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 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
|
60 participants
n=99 Participants
|
60 participants
n=107 Participants
|
120 participants
n=206 Participants
|
|
Body Mass Index
|
29.2 kg/m^2
STANDARD_DEVIATION 9.6 • n=99 Participants
|
28.1 kg/m^2
STANDARD_DEVIATION 6.4 • n=107 Participants
|
28.6 kg/m^2
STANDARD_DEVIATION 8.2 • n=206 Participants
|
|
ASA Physical Status
1-normal health
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
ASA Physical Status
2-mild systemic disease
|
22 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
ASA Physical Status
3-severe systemic disease
|
38 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
ASA Physical Status
4-severe systemic disease that is a constant threat to life
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 150 minutes after neuromuscular reversalGastric emptying as assessed by the area under the paracetamol concentration-time curve by trapezoidal approximation (AUC)
Outcome measures
| Measure |
Sugammadex
n=60 Participants
Sugammadex 2 mg/kg IV once at the end of surgery
Sugammadex: At the end of the surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Sugammadex will be dosed once at 2 mg/kg actual body weight through an intravenous line with brisk flow
|
Neostigmine
n=60 Participants
Neostigmine 0.07 mg/kg to a maximum of 5 mg (+Glycopyrrolate 0.2 mg per 1 mg of neostigmine administered) IV once at the end of surgery
Neostigmine: At the end of surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Neostigmine will be dosed once at 0.07 mg/kg actual body weight to a maximum of 5 mg through an intravenous line with brisk flow. Glycopyrrolate will be coadministered with Neostigmine at a dose of 0.2 mg of Glycopyrrolate per 1.0 mg of Neostigmine administered
|
|---|---|---|
|
Gastric Emptying
|
1120 log(ng*ml-1)*min
Standard Deviation 122
|
1130 log(ng*ml-1)*min
Standard Deviation 117
|
SECONDARY outcome
Timeframe: 30 minutes after the administration of reversal drug.The TOF ratio will be measured in continuous manner every 15 seconds after the administration of reversal drug. The TOF ratio will be measured by the TwitchView electromyograph. The TOF ratio was measured in this study by stimulating the ulnar nerve with four equal stimuli at a frequency of 2 hertz. The TOF ratio is calculated by dividing the amplitude of the muscle response from the fourth stimuli by the amplitude of the muscle response from the first stimuli.
Outcome measures
| Measure |
Sugammadex
n=60 Participants
Sugammadex 2 mg/kg IV once at the end of surgery
Sugammadex: At the end of the surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Sugammadex will be dosed once at 2 mg/kg actual body weight through an intravenous line with brisk flow
|
Neostigmine
n=60 Participants
Neostigmine 0.07 mg/kg to a maximum of 5 mg (+Glycopyrrolate 0.2 mg per 1 mg of neostigmine administered) IV once at the end of surgery
Neostigmine: At the end of surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Neostigmine will be dosed once at 0.07 mg/kg actual body weight to a maximum of 5 mg through an intravenous line with brisk flow. Glycopyrrolate will be coadministered with Neostigmine at a dose of 0.2 mg of Glycopyrrolate per 1.0 mg of Neostigmine administered
|
|---|---|---|
|
Time in Minutes to Reach Train of Four (TOF) Ratio ≥ 0.9 After the Administration of Reversal Drug.
|
5.2 minutes
Standard Deviation 6.3
|
17.5 minutes
Standard Deviation 10.1
|
SECONDARY outcome
Timeframe: 30 days after surgeryGastrointestinal complications will include all of the following: anastomotic leak, postoperative ileus, reoperation, and organ space infection. National Surgical Quality Improvement Project definitions will be used. Active monitoring for these outcomes will occur on an ongoing daily basis until hospital discharge. In addition, chart review and patient phone call will occur 30 days after discharge to assess for complications after discharge.
Outcome measures
| Measure |
Sugammadex
n=60 Participants
Sugammadex 2 mg/kg IV once at the end of surgery
Sugammadex: At the end of the surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Sugammadex will be dosed once at 2 mg/kg actual body weight through an intravenous line with brisk flow
|
Neostigmine
n=60 Participants
Neostigmine 0.07 mg/kg to a maximum of 5 mg (+Glycopyrrolate 0.2 mg per 1 mg of neostigmine administered) IV once at the end of surgery
Neostigmine: At the end of surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Neostigmine will be dosed once at 0.07 mg/kg actual body weight to a maximum of 5 mg through an intravenous line with brisk flow. Glycopyrrolate will be coadministered with Neostigmine at a dose of 0.2 mg of Glycopyrrolate per 1.0 mg of Neostigmine administered
|
|---|---|---|
|
Number of Participants With Gastrointestinal Complications
|
10 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 1 dayThe time to attain pain control and stable respiratory, hemodynamic, and neurologic status after surgery.
Outcome measures
| Measure |
Sugammadex
n=60 Participants
Sugammadex 2 mg/kg IV once at the end of surgery
Sugammadex: At the end of the surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Sugammadex will be dosed once at 2 mg/kg actual body weight through an intravenous line with brisk flow
|
Neostigmine
n=60 Participants
Neostigmine 0.07 mg/kg to a maximum of 5 mg (+Glycopyrrolate 0.2 mg per 1 mg of neostigmine administered) IV once at the end of surgery
Neostigmine: At the end of surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Neostigmine will be dosed once at 0.07 mg/kg actual body weight to a maximum of 5 mg through an intravenous line with brisk flow. Glycopyrrolate will be coadministered with Neostigmine at a dose of 0.2 mg of Glycopyrrolate per 1.0 mg of Neostigmine administered
|
|---|---|---|
|
PACU Recovery Time
|
115 minutes
Standard Deviation 50.3
|
108 minutes
Standard Deviation 56.4
|
SECONDARY outcome
Timeframe: length hospitalization, an average of 1 weekThe time from reversal of neuromuscular blockade to first bowel movement
Outcome measures
| Measure |
Sugammadex
n=60 Participants
Sugammadex 2 mg/kg IV once at the end of surgery
Sugammadex: At the end of the surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Sugammadex will be dosed once at 2 mg/kg actual body weight through an intravenous line with brisk flow
|
Neostigmine
n=60 Participants
Neostigmine 0.07 mg/kg to a maximum of 5 mg (+Glycopyrrolate 0.2 mg per 1 mg of neostigmine administered) IV once at the end of surgery
Neostigmine: At the end of surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Neostigmine will be dosed once at 0.07 mg/kg actual body weight to a maximum of 5 mg through an intravenous line with brisk flow. Glycopyrrolate will be coadministered with Neostigmine at a dose of 0.2 mg of Glycopyrrolate per 1.0 mg of Neostigmine administered
|
|---|---|---|
|
Reversal Time to First Bowel Movement
|
44.3 hours
Standard Deviation 33.8
|
61 hours
Standard Deviation 43
|
SECONDARY outcome
Timeframe: length of hospitalization, an average of 1 weekThe number of days between reversal of neuromuscular blockade and time of discharge order
Outcome measures
| Measure |
Sugammadex
n=60 Participants
Sugammadex 2 mg/kg IV once at the end of surgery
Sugammadex: At the end of the surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Sugammadex will be dosed once at 2 mg/kg actual body weight through an intravenous line with brisk flow
|
Neostigmine
n=60 Participants
Neostigmine 0.07 mg/kg to a maximum of 5 mg (+Glycopyrrolate 0.2 mg per 1 mg of neostigmine administered) IV once at the end of surgery
Neostigmine: At the end of surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Neostigmine will be dosed once at 0.07 mg/kg actual body weight to a maximum of 5 mg through an intravenous line with brisk flow. Glycopyrrolate will be coadministered with Neostigmine at a dose of 0.2 mg of Glycopyrrolate per 1.0 mg of Neostigmine administered
|
|---|---|---|
|
Reversal Time to Discharge Order
|
4.8 days
Standard Deviation 4.9
|
7.82 days
Standard Deviation 19.8
|
Adverse Events
Sugammadex
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Neostigmine
Serious events: 5 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sugammadex
n=60 participants at risk
Sugammadex 2 mg/kg IV once at the end of surgery
Sugammadex: At the end of the surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Sugammadex will be dosed once at 2 mg/kg actual body weight through an intravenous line with brisk flow
|
Neostigmine
n=60 participants at risk
Neostigmine 0.07 mg/kg to a maximum of 5 mg (+Glycopyrrolate 0.2 mg per 1 mg of neostigmine administered) IV once at the end of surgery
Neostigmine: At the end of surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Neostigmine will be dosed once at 0.07 mg/kg actual body weight to a maximum of 5 mg through an intravenous line with brisk flow. Glycopyrrolate will be coadministered with Neostigmine at a dose of 0.2 mg of Glycopyrrolate per 1.0 mg of Neostigmine administered
|
|---|---|---|
|
Immune system disorders
Hypersensitivity Reaction
|
0.00%
0/60 • 30 days
|
0.00%
0/60 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
1.7%
1/60 • Number of events 1 • 30 days
|
3.3%
2/60 • Number of events 2 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Upper Airway Obstruction
|
1.7%
1/60 • Number of events 1 • 30 days
|
5.0%
3/60 • Number of events 3 • 30 days
|
Other adverse events
| Measure |
Sugammadex
n=60 participants at risk
Sugammadex 2 mg/kg IV once at the end of surgery
Sugammadex: At the end of the surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Sugammadex will be dosed once at 2 mg/kg actual body weight through an intravenous line with brisk flow
|
Neostigmine
n=60 participants at risk
Neostigmine 0.07 mg/kg to a maximum of 5 mg (+Glycopyrrolate 0.2 mg per 1 mg of neostigmine administered) IV once at the end of surgery
Neostigmine: At the end of surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Neostigmine will be dosed once at 0.07 mg/kg actual body weight to a maximum of 5 mg through an intravenous line with brisk flow. Glycopyrrolate will be coadministered with Neostigmine at a dose of 0.2 mg of Glycopyrrolate per 1.0 mg of Neostigmine administered
|
|---|---|---|
|
Gastrointestinal disorders
nausea or vomiting
|
11.7%
7/60 • Number of events 7 • 30 days
|
16.7%
10/60 • Number of events 10 • 30 days
|
|
Nervous system disorders
Foul, salty, or metallic taste
|
5.0%
3/60 • Number of events 3 • 30 days
|
5.0%
3/60 • Number of events 3 • 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place